Vulvar Squamous Cell CarcinomaSTRIVENCT06358469
STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
A study testing Surgery and Active Surveillance in people with Vulvar Squamous Cell Carcinoma, run by Canadian Cancer Trials Group at 12 sites in 2 countries.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Squamous Cell Carcinoma
- What is being tested?
- Surgery and Active Surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 10 Dec 2024to 30 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
Canada11 sites, 11 recruiting
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Andra Nica, 905 387-9495
- Recruiting
BCCA - Kelowna
Kelowna, British Columbia, V1Y 5L3
Joni Kooy, 250 712-3900
- Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Annick Pina, 514 890-8444
- Recruiting
The Jewish General Hospital
Montreal, Quebec, H3T 1E2
Susie K.S. Lau, 514 340-8222 ext. 3114
- Recruiting
Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Marie Plante, 418 691-5392
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Genevieve MacAulay Vacheresse
- Recruiting
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, J1H 5N4
Paul Bessette, 819 346-1110 ext. 13120
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Lilian Gien, 416 480-4329
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Stephane Laframboise, 416 946-4501 ext. 2254
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Amy Jamieson, 604 729-1258
- Recruiting
BCCA - Victoria
Victoria, British Columbia, V8R 6V5
Mona Mazgani, 250 519-5578
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
Lois Eva, 649 307-4949
About this study
Official title: STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
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?
Read the 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).
- Conditions
- Vulvar Squamous Cell Carcinoma
- Being tested
- Surgery, Active Surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Re-excision of vulvar cancer margin
Active SurveillanceOther
The investigator will follow the patient to watch for side effects and keep track of patient's health
| Study group | Role | What they receive |
|---|---|---|
| Sub-Study A: Active Surveillance | Active comparator | If the laboratory test results show vulvar cancer is caused by HPV Receives: Other: Active Surveillance |
| Sub-Study B: Re-excision | Active comparator | If the laboratory test results show vulvar cancer is not caused by HPV Receives: Procedure: Surgery |
| Sub-Study B: Active Surveillance | Active comparator | If the laboratory test results show vulvar cancer is not caused by HPV Receives: Other: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (8)
HPV-I and HPV-A VSCC cohorts: Recurrence-free survival
Measured: 3 years
HPV-I and HPV-A VSCC cohorts: Disease-specific survival
Measured: 3 years
HPV-I and HPV-A VSCC cohorts: Overall-survival
Measured: 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
Measured: 3 years
HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30
Measured: 3 years
HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34
Measured: 3 years
HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale
Measured: 3 years
HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start10 Dec 2024
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Australia New Zealand Gynaecological Oncology Group
- Responsible party
- Sponsor
- Investigators
- Amy Jamieson, Study chair, University of British Columbia, Vancouver, BC, CanadaJessica McAlpine, Study chair, BCCA-Vancouver Cancer Centre, Vancouver, BC Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358469
- Sponsor's protocol ID
- VU2
- Acronym
- STRIVE
- Status last verified
- Feb 2026
- First submitted
- 5 Apr 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
- ClinicalTrials.gov ID
- NCT06358469
- Acronym / sponsor ID
- STRIVE / VU2
- Conditions
- Vulvar Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Australia New Zealand Gynaecological Oncology Group
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sub-Study A: Active Surveillance | Active comparator | Other: Active SurveillanceIf the laboratory test results show vulvar cancer is caused by HPV |
| Sub-Study B: Re-excision | Active comparator | Procedure: SurgeryIf the laboratory test results show vulvar cancer is not caused by HPV |
| Sub-Study B: Active Surveillance | Active comparator | Other: Active SurveillanceIf the laboratory test results show vulvar cancer is not caused by HPV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryRe-excision of vulvar cancer margin | Procedure or surgery | Sub-Study B: Re-excision |
| Active SurveillanceThe investigator will follow the patient to watch for side effects and keep track of patient's health | Other | Sub-Study A: Active Surveillance, Sub-Study B: Active Surveillance |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Jamieson study chair
University of British Columbia, Vancouver, BC, Canada
Jessica McAlpine study chair
BCCA-Vancouver Cancer Centre, Vancouver, BC Canada
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Active Surveillance in people with Vulvar Squamous Cell Carcinoma, run by Canadian Cancer Trials Group at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Parulekar (613-533-6430, wparulekar@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.