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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05576831
Registration number
NCT05576831
Ethics application status
Date submitted
1/10/2022
Date registered
13/10/2022
Date last updated
14/08/2023
Titles & IDs
Public title
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
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Scientific title
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision: STRIVE Study
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Secondary ID [1]
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STRIVE
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Universal Trial Number (UTN)
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Trial acronym
STRIVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vulvar Cancer
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Re-excision
No Intervention: HPV-A VSCC - 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.
Experimental: HPV-I VSCC - 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.
Treatment: Surgery: Re-excision
Re-excise (one take back only) Excise scar aiming for 1-2cm margin
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma
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Assessment method [1]
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Duration of time from registration to time of recurrent disease in the vulvar
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Timepoint [1]
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3 years from study enrollment
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Secondary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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through study completion, an average of 1 year
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Secondary outcome [2]
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Patient Reported Outcome EORTC QLQ-C30 - Measures subject's physical, psychological and social functions.
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Assessment method [2]
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Assess the quality of life of cancer patients
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Timepoint [2]
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Preoperatively, after surgery at 4-6 weeks, 4 months, 8 months and 12 months, through study completion, an average of 1 year
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Secondary outcome [3]
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Patient Reported Outcome EORTC QLQ-VU34 vulva-specific module - Measures symptoms or problems related to the genital area
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Assessment method [3]
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Assess issues related to the genital area
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Timepoint [3]
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through study completion, an average of 1 year
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Secondary outcome [4]
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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
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Assessment method [4]
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a validated tool reflecting patient decision making prior to intervention
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Timepoint [4]
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Preoperative
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Secondary outcome [5]
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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.
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Assessment method [5]
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Duration of time from registration to time of death from any cause
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Timepoint [5]
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Every 4 months for first 3 years
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Secondary outcome [6]
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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
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Assessment method [6]
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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
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Timepoint [6]
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through study completion, up to 3 years
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Eligibility
Key inclusion criteria
- 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/01/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
249
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Funding & Sponsors
Primary sponsor type
Other
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Name
British Columbia Cancer Agency
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Gynecologic Cancer Initiative
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Australia New Zealand Gynaecological Oncology Group
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Canadian Cancer Trials Group
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief 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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05576831
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Amy Jamieson, MD
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Address
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BC Cancer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amy Jamieson, MD
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Address
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Country
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Phone
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604-875-4268
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05576831
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