Clinical trial · Interventional
STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
NCT06358469CI-TRIAL-00121534STRIVErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Squamous Cell Carcinoma | Vulvar Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Surveillance | Other | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Sub-Study A: Active Surveillance
- description
- If the laboratory test results show vulvar cancer is caused by HPV
- interventionNames
- Other: Active Surveillance
- type
- ACTIVE_COMPARATOR
- label
- Sub-Study B: Re-excision
- description
- If the laboratory test results show vulvar cancer is not caused by HPV
- interventionNames
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Sub-Study B: Active Surveillance
- description
- If the laboratory test results show vulvar cancer is not caused by HPV
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of vulvar squamous cell carcinoma (VSCC) * Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines * Vulvar resection according to standard of care guidelines * Post-operative margin assessment of tumour clearance, dVIN and p53 status. * Participants' age must be ≥ 18 years old * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French * Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements Exclusion Criteria: * Recurrent vulvar squamous cell carcinoma * Non-squamous cell carcinoma histotypes * Participants referred for/receiving/or previously received adjuvant vulvar radiation or chemotherapy * Primary tumour HPV-I p53 wild-type VSCC * Surgical margins positive for invasive cancer. * Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years * Lymph node positive VSCC or lymph nodes with isolated tumour cells.
References
Publications (0)
Data not yet available
No reference posted for this study.