TriangleNCT00504023 · STUDY IN CONTEXT
Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
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-vulvar-cancer-recurrent-a4d25099
- nct id
- NCT00504023
- trial label
- Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 1
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer-recurrent-a4d25099
- nct id
- NCT00504023
- outcome key
- om-0000
- source section id
- NCT00504023-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Clinical and Histologic Remission
- endpoint definition
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- time origin
- 12 weeks post treatment
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer-recurrent-a4d25099
- nct id
- NCT00504023
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Imiquimod
- regimen
- This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00504023-om-0000#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer-recurrent-a4d25099
- nct id
- NCT00504023
- harm key
- EG000
- source section id
- NCT00504023-ae
- event group key
- EG000
- event group label
- Imiquimod
- serious affected
- 1
- serious at risk
- 8
- other affected
- 8
- other at risk
- 8
- frequency threshold
- 5
- collection period
- 2 years
- 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