STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

Официальное название

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

Обзор

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?

Подробное описание

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).

Вмешательства

• Процедура Surgery
  Re-excision of vulvar cancer margin
• Другое Active Surveillance
  The investigator will follow the patient to watch for side effects and keep track of patient's health

Первичные конечные точки

• 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 [Срок оценки: 3 years]

Вторичные конечные точки (8)

• HPV-I and HPV-A VSCC cohorts: Recurrence-free survival [Срок оценки: 3 years]
• HPV-I and HPV-A VSCC cohorts: Disease-specific survival [Срок оценки: 3 years]
• HPV-I and HPV-A VSCC cohorts: Overall-survival [Срок оценки: 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 [Срок оценки: 3 years]
• HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30 [Срок оценки: 3 years]
• HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34 [Срок оценки: 3 years]
• HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale [Срок оценки: 3 years]
• HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 10 центров

• BCCA - Kelowna — Kelowna
• BCCA - Vancouver — Vancouver
• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton
• Odette Cancer Centre — Toronto
• University Health Network — Toronto
• CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal
• The Jewish General Hospital — Montreal
• Hotel-Dieu de Quebec — Québec
• … и ещё 2 центра

Новая Зеландия · 1 центр

• Auckland City Hospital — Auckland

Идентификаторы

NCT: NCT06358469 · VU2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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