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Vulvar cancer breakthrough: one test could spare women unnecessary surgery

NCT ID NCT06358469

Knowledge-focused Sponsor: Canadian Cancer Trials Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This study is testing whether looking at two biological markers (HPV and p53) in early-stage vulvar cancer can help doctors decide the right amount of surgery. Some women may need less surgery, while others may need more. The study will follow 249 participants for 3 years to see how often the cancer comes back.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 249 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

vulvar squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vulvar squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allan Blair Cancer Centre

    RECRUITING

    Regina, Saskatchewan, S4T 7T1, Canada

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • BCCA - Kelowna

    RECRUITING

    Kelowna, British Columbia, V1Y 5L3, Canada

  • BCCA - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • BCCA - Victoria

    RECRUITING

    Victoria, British Columbia, V8R 6V5, Canada

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • CIUSSS de l'Estrie - Centre hospitalier

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Hotel-Dieu de Quebec

    RECRUITING

    Québec, Quebec, G1R 2J6, Canada

  • Juravinski Cancer Centre at Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Odette Cancer Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • The Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

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