Recruiting

Observational StudySTRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

Sponsor:

Canadian Cancer Trials Group

Code:

NCT06358469

Conditions

Vulvar Squamous Cell Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgery

Active Surveillance

Study Details

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

Study ID

NCT06358469

Start date

Dec 10, 2024

Status verified date

Feb, 2026

Completion date

Nov 30, 2031

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

249 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sub-Study A: Active Surveillance

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

active comparator: Sub-Study B: Re-excision

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

active comparator: Sub-Study B: Active Surveillance

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

Interventions

Surgery

Re-excision of vulvar cancer margin

Active Surveillance

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

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Wendy Parulekar

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

Locations

BCCA - Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

Contacts

Joni Kooy

250 712-3900

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Amy Jamieson

604 729-1258

BCCA - Victoria

Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Contacts

Mona Mazgani

250 519-5578

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Andra Nica

905 387-9495

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Lilian Gien

416 480-4329

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Stephane Laframboise

416 946-4501

CHUM-Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Annick Pina

514 890-8444

The Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Susie K.S. Lau

514 340-8222

Hotel-Dieu de Quebec

Recruiting

Québec, Quebec, Canada, G1R 2J6

Contacts

Marie Plante

418 691-5392

CIUSSS de l'Estrie - Centre hospitalier

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Paul Bessette

819 346-1110

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Aug 11, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-08-11.