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Recruiting NCT06358469

STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

No phase Interventional Vulvar Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery, Active Surveillance.
Who it may be relevant to
Registry conditions: Vulvar Squamous Cell Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision

Overview

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?

Detailed description

This study is being done to find out if these approaches are better or worse than the usual approach for early-stage vulvar cancer. The usual approach is defined as care most people get for early-stage vulvar cancer.

The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor in deciding whether additional surgery should be recommended.

For patients deciding to take part in this study, the treatment that will be recommended will be based on laboratory testing of the cancer. The laboratory assessments include a test to determine if the cancer is caused by the Human Papilloma Virus (HPV) or not caused by HPV. If the laboratory test results show the vulvar cancer is caused by HPV, the study doctor will recommend the patient participate in sub-study A. In sub-study A, the patient will receive no additional surgery (observation). If the laboratory test results show the vulvar cancer is not caused by HPV, the study doctor will recommend the patient participate in sub-study B. In sub-study B, patients will receive either a second surgery or no additional surgery (observation).

Interventions

  • Procedure Surgery
    Re-excision of vulvar cancer margin
  • Other Active Surveillance
    The investigator will follow the patient to watch for side effects and keep track of patient's health

Primary outcome measures

  • Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance [Time frame: 3 years]
Secondary outcome measures (8)
  • HPV-I and HPV-A VSCC cohorts: Recurrence-free survival [Time frame: 3 years]
  • HPV-I and HPV-A VSCC cohorts: Disease-specific survival [Time frame: 3 years]
  • HPV-I and HPV-A VSCC cohorts: Overall-survival [Time frame: 3 years]
  • HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L [Time frame: 3 years]
  • HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30 [Time frame: 3 years]
  • HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34 [Time frame: 3 years]
  • HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale [Time frame: 3 years]
  • HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn [Time frame: 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 10 centers
  • BCCA - Kelowna — Kelowna
  • BCCA - Vancouver — Vancouver
  • Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton
  • Odette Cancer Centre — Toronto
  • University Health Network — Toronto
  • CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal
  • The Jewish General Hospital — Montreal
  • Hotel-Dieu de Quebec — Québec
  • … and 2 more centers
New Zealand · 1 center
  • Auckland City Hospital — Auckland

Identifiers

NCT: NCT06358469 · VU2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗