STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 249
- 试验地点
- 16
- 主要终点
- 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
研究概览
简要总结
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?
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Sub-Study A: Active Surveillance
If the laboratory test results show vulvar cancer is caused by HPV
干预措施: Active Surveillance (Other)
Sub-Study B: Re-excision
If the laboratory test results show vulvar cancer is not caused by HPV
干预措施: Surgery (Procedure)
Sub-Study B: Active Surveillance
If the laboratory test results show vulvar cancer is not caused by HPV
干预措施: Active Surveillance (Other)
结局指标
主要结局
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
时间窗: 3 years
次要结局
- HPV-I and HPV-A VSCC cohorts: Recurrence-free survival(3 years)
- HPV-I and HPV-A VSCC cohorts: Disease-specific survival(3 years)
- HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn(3 years)
- HPV-I and HPV-A VSCC cohorts: Overall-survival(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(3 years)
- HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30(3 years)
- HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34(3 years)
- HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale(3 years)