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← Small Intestine Cancer

NCT00569309 · STUDY IN CONTEXT

Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV \& EBV tetramer responses after autologous transplant for myeloma

Source null

→

secondary · POSTED

Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFβ and Interleukin-10 (IL-10)

Inadequate material collected to perform these assays

→

secondary · POSTED

Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes

Quality of Life surveys were not completed

→

secondary · POSTED

The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.

Not all patients data was available due to incomplete surveys

→

secondary · POSTED

Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.

Source null

→

secondary · POSTED

Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials

Data was not collect and analyzed for reporting purposes

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Unnamed quality-of-life measure · Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer
nct id
NCT00569309
qol key
qol-0002
source section id
NCT00569309-om-0002
source outcome index
2
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes
measure definition
Source null
time frame
Up to 3 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Quality of Life surveys were not completed
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Brief Pain Inventory · Quality of Life, Including Brief Pain Inventory

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer
nct id
NCT00569309
qol key
qol-0003
source section id
NCT00569309-om-0003
source outcome index
3
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Quality of Life, Including Brief Pain Inventory
measure definition
The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.
time frame
Up to 3 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Not all patients data was available due to incomplete surveys
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life, Including Fatigue

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer
nct id
NCT00569309
qol key
qol-0004
source section id
NCT00569309-om-0004
source outcome index
4
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life, Including Fatigue
measure definition
Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.
time frame
Up to 3 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer
nct id
NCT00569309
qol key
qol-0005
source section id
NCT00569309-om-0005
source outcome index
5
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials
measure definition
Source null
time frame
Up to 3 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Data was not collect and analyzed for reporting purposes
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-small-intestine-cancer
nct id
NCT00569309
trial label
Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0000
    source section id
    NCT00569309-om-0000
    source outcome index
    0
    endpoint
    Number of Participants Experiencing Immune Reconstitution
    endpoint definition
    Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV \& EBV tetramer responses after autologous transplant for myeloma
    time origin
    Up to 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0001
    source section id
    NCT00569309-om-0001
    source outcome index
    1
    endpoint
    Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFβ and Interleukin-10 (IL-10)
    endpoint definition
    Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFβ and Interleukin-10 (IL-10)
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Inadequate material collected to perform these assays
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0002
    source section id
    NCT00569309-om-0002
    source outcome index
    2
    endpoint
    Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes
    endpoint definition
    Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Quality of Life surveys were not completed
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0003
    source section id
    NCT00569309-om-0003
    source outcome index
    3
    endpoint
    Quality of Life, Including Brief Pain Inventory
    endpoint definition
    The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Not all patients data was available due to incomplete surveys
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0004
    source section id
    NCT00569309-om-0004
    source outcome index
    4
    endpoint
    Quality of Life, Including Fatigue
    endpoint definition
    Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0005
    source section id
    NCT00569309-om-0005
    source outcome index
    5
    endpoint
    Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials
    endpoint definition
    Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data was not collect and analyzed for reporting purposes
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Prevnar
    regimen
    The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00569309-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Prevnar
    regimen
    The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00569309-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Prevnar
    regimen
    The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00569309-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Prevnar
    regimen
    The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00569309-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Prevnar
    regimen
    The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00569309-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Prevnar
    regimen
    The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00569309-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    harm key
    EG000
    source section id
    NCT00569309-ae
    event group key
    EG000
    event group label
    Prevnar
    serious affected
    0
    serious at risk
    30
    other affected
    30
    other at risk
    30
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    qol key
    qol-0002
    source section id
    NCT00569309-om-0002
    source outcome index
    2
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes
    measure definition
    Source null
    time frame
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Quality of Life surveys were not completed
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    qol key
    qol-0003
    source section id
    NCT00569309-om-0003
    source outcome index
    3
    instrument
    Brief Pain Inventory
    instrument basis
    matched 'brief pain inventory' in the study's own wording
    scale title
    Quality of Life, Including Brief Pain Inventory
    measure definition
    The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.
    time frame
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Not all patients data was available due to incomplete surveys
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    qol key
    qol-0004
    source section id
    NCT00569309-om-0004
    source outcome index
    4
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life, Including Fatigue
    measure definition
    Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.
    time frame
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-intestine-cancer
    nct id
    NCT00569309
    qol key
    qol-0005
    source section id
    NCT00569309-om-0005
    source outcome index
    5
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials
    measure definition
    Source null
    time frame
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Data was not collect and analyzed for reporting purposes
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice