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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05576831

Registration number

NCT05576831

Ethics application status

Date submitted

1/10/2022

Date registered

13/10/2022

Date last updated

19/08/2024

Titles & IDs

Public title

STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision

Scientific title

STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision: STRIVE Study

Secondary ID [1]

STRIVE

Universal Trial Number (UTN)

Trial acronym

STRIVE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vulvar Cancer

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

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.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

1/01/2025

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/12/2025

Actual

Sample size

Target

249

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Primary sponsor type

Other

Name

British Columbia Cancer Agency

Address

Country

Ethics approval

Ethics application status

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.

Trial website

https://clinicaltrials.gov/study/NCT05576831

Trial related presentations / publications

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

Contacts

Principal investigator

Name

Amy Jamieson, MD

Address

BC Cancer

Country

Phone

Fax

Contact person for public queries

Name

Amy Jamieson, MD

Address

Country

Phone

604-875-4268

Fax

[email protected]

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05576831

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05576831