TriangleNCT00591305 · STUDY IN CONTEXT
New Therapy of Laryngeal Papilloma In Children
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. 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
vocal lesion size and area after 5 month with surgery visible lesion found in \>50% of the treated tissue area, after surgery
determine side-effect by comparing Estradiol level in blood before and after treatment
determine side-effect by comparing Estradiol level in blood before and after treatment
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-papilloma
- nct id
- NCT00591305
- trial label
- New Therapy of Laryngeal Papilloma In Children
- 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.
- 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
- 3
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-papilloma
- nct id
- NCT00591305
- outcome key
- om-0000
- source section id
- NCT00591305-om-0000
- source outcome index
- 0
- endpoint
- Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months
- endpoint definition
- vocal lesion size and area after 5 month with surgery visible lesion found in \>50% of the treated tissue area, after surgery
- time origin
- Recurrence of pailloma at 5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- participants received at least one of two interventions
- 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-papilloma
- nct id
- NCT00591305
- outcome key
- om-0001
- source section id
- NCT00591305-om-0001
- source outcome index
- 1
- endpoint
- Estradiol Level in Blood Pre Treatment
- endpoint definition
- determine side-effect by comparing Estradiol level in blood before and after treatment
- time origin
- Before treatment at baseline
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- failure for any meaningful analysis as only 1 participant in this study
- 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-papilloma
- nct id
- NCT00591305
- outcome key
- om-0002
- source section id
- NCT00591305-om-0002
- source outcome index
- 2
- endpoint
- Estradiol Level in Blood Post Treatment
- endpoint definition
- determine side-effect by comparing Estradiol level in blood before and after treatment
- time origin
- 5 month
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- failure for any meaningful analysis as only 1 participant in this study
- 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-papilloma
- nct id
- NCT00591305
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Intervention
- regimen
- laser+dietary DIM
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00591305-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-papilloma
- nct id
- NCT00591305
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- laser only without DIM
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00591305-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-papilloma
- nct id
- NCT00591305
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Intervention
- regimen
- laser+diatary DIM
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00591305-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-papilloma
- nct id
- NCT00591305
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- laser only without DIM
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00591305-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-papilloma
- nct id
- NCT00591305
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Intervention
- regimen
- laser+diatary DIM
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00591305-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-papilloma
- nct id
- NCT00591305
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- laser only without DIM
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00591305-om-0002#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-papilloma
- nct id
- NCT00591305
- harm key
- EG000
- source section id
- NCT00591305-ae
- event group key
- EG000
- event group label
- PDL+DIM Pill
- serious affected
- 0
- serious at risk
- 1
- other affected
- 0
- other at risk
- 1
- frequency threshold
- 0
- collection period
- 3 months after surgery
- 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-papilloma
- nct id
- NCT00591305
- harm key
- EG001
- source section id
- NCT00591305-ae
- event group key
- EG001
- event group label
- PDL+Placebo Pill
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- 3 months after surgery
- 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
- setting source links
Preserved source evidence · Not medical advice