NCT02624388 · STUDY IN CONTEXT

Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)

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

Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy

Source null

→

secondary · POSTED

Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy

Source null

→

secondary · POSTED

This includes hearing loss/tinnitus, motor neuropathy, oral mucositis

Source null

→

secondary · POSTED

This includes hearing loss/tinnitus, motor neuropathy, oral mucositis

Source null

→

secondary · POSTED

This includes hearing loss/tinnitus, motor neuropathy, oral mucositis

Source null

→

secondary · POSTED

Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event

Source null

→

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

FACT · Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered

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-medulloblastoma-pediatric
nct id: NCT02624388
qol key: qol-0009
source section id: NCT02624388-om-0009
source outcome index: 9
instrument: FACT
instrument basis: matched 'factor' in the study's own wording
scale title: Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered
measure definition: Source null
time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
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 →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-medulloblastoma-pediatric
nct id: NCT02624388
trial label: Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
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: 4
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0000
source section id
NCT02624388-om-0000
source outcome index
0
endpoint
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
endpoint definition
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
time origin
From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
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
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0001
source section id
NCT02624388-om-0001
source outcome index
1
endpoint
Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy
endpoint definition
Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy
time origin
Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
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
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0002
source section id
NCT02624388-om-0002
source outcome index
2
endpoint
Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
endpoint definition
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
time origin
From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
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
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0003
source section id
NCT02624388-om-0003
source outcome index
3
endpoint
Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
endpoint definition
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
time origin
From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
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
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0004
source section id
NCT02624388-om-0004
source outcome index
4
endpoint
Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria
endpoint definition
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
time origin
From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
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
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0005
source section id
NCT02624388-om-0005
source outcome index
5
endpoint
Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
endpoint definition
Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
time origin
From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
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

arms

release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0000
arm key
OG000
arm label
Arm A: Genistein Followed by Placebo
regimen
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0000
arm key
OG001
arm label
Arm B: Placebo Followed by Genistein
regimen
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0001
arm key
OG000
arm label
Arm A: Genistein Followed by Placebo
regimen
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0001
arm key
OG001
arm label
Arm B: Placebo Followed by Genistein
regimen
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0002
arm key
OG000
arm label
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles
regimen
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0002
arm key
OG001
arm label
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles
regimen
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0002
arm key
OG002
arm label
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
regimen
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0002
arm key
OG003
arm label
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
regimen
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0003
arm key
OG000
arm label
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles
regimen
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0003
arm key
OG001
arm label
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles
regimen
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0003
arm key
OG002
arm label
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
regimen
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
outcome key
om-0003
arm key
OG003
arm label
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
regimen
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02624388-om-0003#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
harm key
EG000
source section id
NCT02624388-ae
event group key
EG000
event group label
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
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
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
harm key
EG001
source section id
NCT02624388-ae
event group key
EG001
event group label
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
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
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
harm key
EG002
source section id
NCT02624388-ae
event group key
EG002
event group label
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
serious affected
1
serious at risk
2
other affected
0
other at risk
2
frequency threshold
0
collection period
All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
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
release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
harm key
EG003
source section id
NCT02624388-ae
event group key
EG003
event group label
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
serious affected
1
serious at risk
2
other affected
0
other at risk
2
frequency threshold
0
collection period
All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
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

release id
clinical-indications-draft-1
disease state id
ds-medulloblastoma-pediatric
nct id
NCT02624388
qol key
qol-0009
source section id
NCT02624388-om-0009
source outcome index
9
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered
measure definition
Source null
time frame
From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
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

setting source links

Preserved source evidence · Not medical advice