Vulvar CancerSTRIVENCT05576831
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
A study testing Re-excision in people with Vulvar Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Cancer
- What is being tested?
- Re-excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2024to 25 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 primary diagnosis of vulvar squamous cell carcinoma
- Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
- Margin status after primary surgery:
- HPV-I VSCC: margins are negative for cancer but <8mm, and/or positive for dVIN, and/or positive for p53 abnormality on IHC
- HPV-A VSCC: margins are negative for cancer but <8mm (regardless of in-situ (HSIL) margin status)
- Age ≥18 years old
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.
Who cannot join
- Recurrent vulvar squamous cell carcinoma
- Non-squamous cell carcinoma histotypes
- FIGO stage III- IV disease
- Patients referred for adjuvant radiation for close margins
- Margins positive for cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Cancer - Vancouver Centre
Vancouver, British Columbia, V5Z 2E6
Jessica McAlpine, 604-875-4268, Jessica.Mcalpine@vch.ca
Jessica McAlpine, MD
About this study
Official title: STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision: STRIVE Study
Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different pathways. One pathway is associated with human papillomavirus (HPV) infection, and another is related to chronic inflammatory skin conditions (and not HPV). The VSCCs arising from these two principal pathways; HPV- associated (HPV A) and HPV-independent (HPV I), behave differently with different risks of recurrence, and different response to treatments. HPV-I VSCC are further defined by mutations in TP53 (Tumor Protein 53), which identify a group of patients with aggressive disease. Currently treatment is the same for all women with vulvar cancer, and consequently many women may be overtreated, and many women are not treated enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no longer be appropriate. The investigators aim in this study is to see if personalizing surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve outcomes.
Read the detailed description
Purpose:
The aim of this prospective study is to determine if implementation of HPV(p16) and p53 stratified management algorithms will improve outcomes for women with VSCC.
Hypothesis:
Primary:
Molecular stratification of VSCC, using margin status for both HPV and p53 pathology to direct surgical management, will improve clinical outcomes.
Patient Reported Outcomes (PRO) Hypothesis:
In women with HPV-associated (HPV-A) VSCC who undergo less radical surgery, treatment-related side effects will be reduced, health-related quality of life will be improved, and fear of cancer recurrence will not be increased, when compared to patients who undergoing standard surgery. PROs that are expected to be improved in this subgroup are: satisfaction with body image, frequency and enjoyment of sexual activity, urinary symptoms, and genital pain. In women with HPV-independent (HPV-I) VSCC, the expected PRO/HRQL (Health-related quality of life) trajectory is expected to remain unchanged in the intervention group compared to the observation group, and fear of recurrence will be decreased.
Justification:
Most VSCC guidelines today recommend tumour-free pathological margins of 8mm or more to adequately treat the primary tumour. These guidelines are based on retrospective data which did not stratify patients based on HPV or TP53 mutation status.
HPV-I VSCC: there is now data suggesting investigators are undertreating these patients and that surgical margins defined by proximity of invasive disease, presence of preinvasive disease and p53 IHC (Immunohistochemistry) status will guide the need for re-excision and optimize local disease control.
Goal in HPV-I VSCC = demonstrating re-excision to achieve clear margins will improve outcomes.
HPV-A VSCC: there is data supporting that investigators are likely overtreating these patients, and the absence of invasive disease at the resection margin will be sufficient without loss of local control and will improve patient reported outcomes.
Goal in HPV-A VSCC= demonstrating de-escalation of surgery is safe(and will improve QoL).
Objectives:
Primary Objective:
To determine if implementation of HPV and p53 stratified algorithms to guide surgical management will improve outcomes in patients with VSCC; based on 3-year local recurrence rates in both HPV-I and HPV-A disease
Secondary Objectives:
- Determine the health economic impact (EQ-5D) of implementation of HPV and p53 stratified treatment algorithms
- Determine the patient reported outcomes (EORTC QLQ (Quality of Life Questionnaire) -C30 and EORTC QLQ-VU34), patient decisional conflict, patient satisfaction /acceptance with HPV and p53 stratified care in VSCC
- Determine the disease specific survival (DSS) and overall survival (OS) for HPV-I and HPV-A VSCC managed per algorithms
- Determine the feasibility of implementation of routine p16 and p53 IHC reporting in VSCC pathology (proportion of patients who had p53 and p16 IHC successfully performed in an acceptable turnaround time ie >85% of patients within 21 days of surgery)
RESEARCH DESIGN:
The HPV-I arm of the study will be conducted as a phase II, randomised control trial and the HPV-A arm of the study will be a prospective trial.
STATISTICAL ANALYSIS:
The Kaplan-Meier method will be used to estimate 3-year rates of recurrence-free survival, vulvar cancer-specific survival, and overall survival and associated 95% confidence interval with the events defined as any recurrence or death for recurrence-free survival, death due to vulvar cancer for vulvar cancer-specific survival, and death due to any cause for overall survival. Women without the event observed at the time of analysis will be censored at the last follow-up.
- Conditions
- Vulvar Cancer
- Being tested
- Re-excision
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-excisionProcedure or surgery
Re-excise (one take back only) Excise scar aiming for 1-2cm margin
| Study group | Role | What they receive |
|---|---|---|
| HPV-A VSCC | No intervention | Patients with HPV-A VSCC and margins that are negative for cancer but <8mm (regardless of in-situ (HSIL) margin status) will be eligible for the de-escalation prospective study. |
| HPV-I VSCC | Experimental | If the margins are negative for cancer but <8mm, or positive for Differentiated vulvar intraepithelial neoplasia (dVIN), and/or positive for p53 abnormality on IHC, these patients will be randomized (2:1) to further re-excision vs observation only. Receives: Procedure: Re-excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma
Duration of time from registration to time of recurrent disease in the vulvar
Measured: 3 years from study enrollment
Secondary outcomes (6)
Health Economic Impact of implementation of HPV and p53 stratified treatment algorithms - Measure the delta in surgical parameters (surgical take backs, longer hospital stay for more extensive surgery)
Health utility scores will be obtained through multi-attribute quality of life instruments such as the EQ-5D-5L. Outcome measure will be the incremental cost-effectiveness ratio, which is defined as the difference in cost divided by the difference in effectiveness between the 2 treatment strategies.
Measured: through study completion, an average of 1 year
Patient Reported Outcome EORTC QLQ-C30 - Measures subject's physical, psychological and social functions.
Assess the quality of life of cancer patients
Measured: Preoperatively, after surgery at 4-6 weeks, 4 months, 8 months and 12 months, through study completion, an average of 1 year
Patient Reported Outcome EORTC QLQ-VU34 vulva-specific module - Measures symptoms or problems related to the genital area
Assess issues related to the genital area
Measured: through study completion, an average of 1 year
Patient Decisional Conflict Scale - Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after treatment
a validated tool reflecting patient decision making prior to intervention
Measured: Preoperative
Disease-specific survival is defined as the time from study enrolment to the time of death from vulvar cancer. Overall survival is defined as the time from study enrolment to the time of death from any cause.
Duration of time from registration to time of death from any cause
Measured: Every 4 months for first 3 years
Proportion of patients who had p16 IHC and in HPV-I VSCC who had p53 IHC performed on resection margin in an acceptable turnaround time ie >85% of patients tumours had this performed and reported within 21 days of surgery
proportion of patients who had p53 and p16 IHC successfully performed in an acceptable turnaround time ie >85% of patients within 21 days of surgery
Measured: through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start25 Nov 2024
- Primary completion25 Nov 2031 (estimated)
- Study completion25 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 CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Gynecologic Cancer Initiative, Australia New Zealand Gynaecological Oncology Group, Canadian Cancer Trials Group
- Responsible party
- Principal investigator, Jessica McAlpine, British Columbia Cancer Agency
- Investigators
- Amy Jamieson, MD, Principal investigator, BC Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576831
- Sponsor's protocol ID
- STRIVE
- Acronym
- STRIVE
- Status last verified
- Jan 2026
- First submitted
- 1 Oct 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 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: STRIVE Study
- ClinicalTrials.gov ID
- NCT05576831
- Acronym / sponsor ID
- STRIVE / STRIVE
- Conditions
- Vulvar Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Gynecologic Cancer Initiative, Australia New Zealand Gynaecological Oncology Group, Canadian Cancer Trials Group
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 Nov 2031 (estimated)
- Study completion
- 25 Nov 2031 (estimated)
- First posted
- 13 Oct 2022 (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.
Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different pathways. One pathway is associated with human papillomavirus (HPV) infection, and another is related to chronic inflammatory skin conditions (and not HPV). The VSCCs arising from these two principal pathways; HPV- associated (HPV A) and HPV-independent (HPV I), behave differently with different risks of recurrence, and different response to treatments. HPV-I VSCC are further defined by mutations in TP53 (Tumor Protein 53), which identify a group of patients with aggressive disease. Currently treatment is the same for all women with vulvar cancer, and consequently many women may be overtreated, and many women are not treated enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no longer be appropriate. The investigators aim in this study is to see if personalizing surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve outcomes.
Detailed description
Purpose:
The aim of this prospective study is to determine if implementation of HPV(p16) and p53 stratified management algorithms will improve outcomes for women with VSCC.
Hypothesis:
Primary:
Molecular stratification of VSCC, using margin status for both HPV and p53 pathology to direct surgical management, will improve clinical outcomes.
Patient Reported Outcomes (PRO) Hypothesis:
In women with HPV-associated (HPV-A) VSCC who undergo less radical surgery, treatment-related side effects will be reduced, health-related quality of life will be improved, and fear of cancer recurrence will not be increased, when compared to patients who undergoing standard surgery. PROs that are expected to be improved in this subgroup are: satisfaction with body image, frequency and enjoyment of sexual activity, urinary symptoms, and genital pain. In women with HPV-independent (HPV-I) VSCC, the expected PRO/HRQL (Health-related quality of life) trajectory is expected to remain unchanged in the intervention group compared to the observation group, and fear of recurrence will be decreased.
Justification:
Most VSCC guidelines today recommend tumour-free pathological margins of 8mm or more to adequately treat the primary tumour. These guidelines are based on retrospective data which did not stratify patients based on HPV or TP53 mutation status.
HPV-I VSCC: there is now data suggesting investigators are undertreating these patients and that surgical margins defined by proximity of invasive disease, presence of preinvasive disease and p53 IHC (Immunohistochemistry) status will guide the need for re-excision and optimize local disease control.
Goal in HPV-I VSCC = demonstrating re-excision to achieve clear margins will improve outcomes.
HPV-A VSCC: there is data supporting that investigators are likely overtreating these patients, and the absence of invasive disease at the resection margin will be sufficient without loss of local control and will improve patient reported outcomes.
Goal in HPV-A VSCC= demonstrating de-escalation of surgery is safe(and will improve QoL).
Objectives:
Primary Objective:
To determine if implementation of HPV and p53 stratified algorithms to guide surgical management will improve outcomes in patients with VSCC; based on 3-year local recurrence rates in both HPV-I and HPV-A disease
Secondary Objectives:
- Determine the health economic impact (EQ-5D) of implementation of HPV and p53 stratified treatment algorithms
- Determine the patient reported outcomes (EORTC QLQ (Quality of Life Questionnaire) -C30 and EORTC QLQ-VU34), patient decisional conflict, patient satisfaction /acceptance with HPV and p53 stratified care in VSCC
- Determine the disease specific survival (DSS) and overall survival (OS) for HPV-I and HPV-A VSCC managed per algorithms
- Determine the feasibility of implementation of routine p16 and p53 IHC reporting in VSCC pathology (proportion of patients who had p53 and p16 IHC successfully performed in an acceptable turnaround time ie >85% of patients within 21 days of surgery)
RESEARCH DESIGN:
The HPV-I arm of the study will be conducted as a phase II, randomised control trial and the HPV-A arm of the study will be a prospective trial.
STATISTICAL ANALYSIS:
The Kaplan-Meier method will be used to estimate 3-year rates of recurrence-free survival, vulvar cancer-specific survival, and overall survival and associated 95% confidence interval with the events defined as any recurrence or death for recurrence-free survival, death due to vulvar cancer for vulvar cancer-specific survival, and death due to any cause for overall survival. Women without the event observed at the time of analysis will be censored at the last follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV-A VSCC | No intervention | –Patients with HPV-A VSCC and margins that are negative for cancer but <8mm (regardless of in-situ (HSIL) margin status) will be eligible for the de-escalation prospective study. |
| HPV-I VSCC | Experimental | Procedure: Re-excisionIf the margins are negative for cancer but <8mm, or positive for Differentiated vulvar intraepithelial neoplasia (dVIN), and/or positive for p53 abnormality on IHC, these patients will be randomized (2:1) to further re-excision vs observation only. |
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 primary diagnosis of vulvar squamous cell carcinoma
- Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
- Margin status after primary surgery:
- Age ≥18 years old
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.
Key exclusion criteria (5 listed)
- Recurrent vulvar squamous cell carcinoma
- Non-squamous cell carcinoma histotypes
- FIGO stage III- IV disease
- Patients referred for adjuvant radiation for close margins
- Margins positive for 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 |
|---|---|---|
| Re-excisionRe-excise (one take back only) Excise scar aiming for 1-2cm margin | Procedure or surgery | HPV-I VSCC |
Primary outcome
Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma
Time frame: 3 years from study enrollment
Duration of time from registration to time of recurrent disease in the vulvar
6 secondary outcomes
Health Economic Impact of implementation of HPV and p53 stratified treatment algorithms - Measure the delta in surgical parameters (surgical take backs, longer hospital stay for more extensive surgery)
Time frame: through study completion, an average of 1 year
Patient Reported Outcome EORTC QLQ-C30 - Measures subject's physical, psychological and social functions.
Time frame: Preoperatively, after surgery at 4-6 weeks, 4 months, 8 months and 12 months, through study completion, an average of 1 year
Patient Reported Outcome EORTC QLQ-VU34 vulva-specific module - Measures symptoms or problems related to the genital area
Time frame: through study completion, an average of 1 year
Patient Decisional Conflict Scale - Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after treatment
Time frame: Preoperative
Disease-specific survival is defined as the time from study enrolment to the time of death from vulvar cancer. Overall survival is defined as the time from study enrolment to the time of death from any cause.
Time frame: Every 4 months for first 3 years
Proportion of patients who had p16 IHC and in HPV-I VSCC who had p53 IHC performed on resection margin in an acceptable turnaround time ie >85% of patients tumours had this performed and reported within 21 days of surgery
Time frame: through study completion, up to 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 3 Feb 2026.
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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, MD principal investigator
BC Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-excision in people with Vulvar Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
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 5 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Amy Jamieson, MD (604-875-4268, Amy.Jamieson@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma (time frame: 3 years from study enrollment). 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 3 Feb 2026.