Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06358469

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

Led by Canadian Cancer Trials Group · Updated on 2026-05-12

249

Participants Needed

11

Research Sites

363 weeks

Total Duration

On this page

Sponsors

C

Canadian Cancer Trials Group

Lead Sponsor

A

Australia New Zealand Gynaecological Oncology Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of vulvar squamous cell carcinoma (VSCC)
  • Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines
  • Vulvar resection performed according to standard care guidelines
  • Post-operative assessment of tumour margin clearance, dVIN, and p53 status
  • Participant is at least 18 years old
  • Participant is able and willing to complete quality of life and health utility questionnaires in English or French
  • Participant has given informed consent according to local and regulatory requirements
Not Eligible

You will not qualify if you...

  • Recurrent vulvar squamous cell carcinoma
  • Non-squamous cell carcinoma types
  • Receiving or previously received adjuvant vulvar radiation or chemotherapy
  • Primary tumour HPV-independent p53 wild-type VSCC
  • Surgical margins positive for invasive cancer
  • History of other cancers except adequately treated non-melanoma skin cancer, treated in-situ cervical cancer, or other solid tumors with no evidence of disease for at least 5 years
  • Lymph node positive VSCC or lymph nodes with isolated tumour cells

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

BCCA - Kelowna

Kelowna, British Columbia, Canada, V1Y 5L3

Actively Recruiting

2

BCCA - Vancouver

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

3

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada, L8V 5C2

Actively Recruiting

4

Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

5

University Health Network

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

6

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada, H2X 3E4

Actively Recruiting

7

The Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Not Yet Recruiting

8

Hotel-Dieu de Quebec

Québec, Quebec, Canada, G1R 2J6

Actively Recruiting

9

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

10

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada, S4T 7T1

Actively Recruiting

11

Auckland City Hospital

Auckland, New Zealand, 1023

Actively Recruiting

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Research Team

W

Wendy Parulekar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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