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

NCT06358469 | Recruiting DMC

• 1 other identifier: VU2
• Study Type: interventional
• Target: 249
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Vulvar Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (8)

• HPV-I and HPV-A VSCC cohorts: Recurrence-free survival

  3 years

• HPV-I and HPV-A VSCC cohorts: Disease-specific survival

  3 years

• HPV-I and HPV-A VSCC cohorts: Overall-survival

  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

  3 years

• HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30

  3 years

Study Arms (3)

Sub-Study A: Active Surveillance

ACTIVE COMPARATOR

If the laboratory test results show vulvar cancer is caused by HPV

Other: Active Surveillance

Sub-Study B: Re-excision

ACTIVE COMPARATOR

If the laboratory test results show vulvar cancer is not caused by HPV

Procedure: Surgery

Sub-Study B: Active Surveillance

ACTIVE COMPARATOR

If the laboratory test results show vulvar cancer is not caused by HPV

Other: Active Surveillance

Interventions

Surgery PROCEDURE

Re-excision of vulvar cancer margin

Sub-Study B: Re-excision

Active Surveillance OTHER

The investigator will follow the patient to watch for side effects and keep track of patient's health

Sub-Study A: Active Surveillance; Sub-Study B: Active Surveillance

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Australia New Zealand Gynaecological Oncology Group: collaborator
• Canadian Cancer Trials Group: lead

Study Sites (10)

BCCA - Kelowna

Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

BCCA - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

RECRUITING

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative; Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Amy Jamieson

  University of British Columbia, Vancouver, BC, Canada

  STUDY CHAIR

• Jessica McAlpine

  BCCA-Vancouver Cancer Centre, Vancouver, BC Canada

  STUDY CHAIR

Central Study Contacts

Wendy Parulekar

CONTACT

613-533-6430; wparulekar@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): November 30, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); CA (9)