Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 10
- 主要终点
- Specificity of plasma circulating tumor DNA detection as a test to detect any (local or distant) relapse in patients who have been curatively treated for HPV-induced invasive pelvic cancer (cervix, anal canal, vagina, vulva, penis).
研究概览
简要总结
ctDNA detection in patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up.
详细描述
Patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up will be included.
These patients will be followed up during 30 months (2.5 years) (if no relapse occurred before) with ctDNA detection performed at each hospital visit. At each visit, clinical, biological (squamous cell carcinoma (SCC) serum marker will be done systematically) and radiological/pathology (if any) results will be prospectively collected in the study.
For the patients who have a relapse or new HPV-induced invasive cancer before 30 months, the follow-up will be discontinued at the date of the relapse.
For the patients who will have completed their follow-up for the study (2.5 years) with no relapse or new HPV-induced invasive cancer, they will be followed up for 6 months (+ 14 days), to collect any late relapse (if any). None specific study procedure will be performed during this period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Patient curatively treated within the past 3 years for:
- •a HPV-induced stage Ib3, Ic, II or III cervix cancer
- •a HPV-induced stage II or III anal canal, vagina, vulva or penis cancer
- •Patient with no evidence of any invasive tumor at inclusion (clinical and, if any, radiological exams).
- •Age ≥ 18 years
- •Availability of HPV genotyping of the treated cancer and/or archived tumor tissue available.
- •Patient who a follow-up visit is scheduled in the including center at least twice a year.
- •Patient being affiliated to the French social security.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patient presenting with active invasive tumor masses (e.g. stage IV cancer).
- •Patient deprived from ability to decide on her own or placed under the authority of a tutor.
- •Patient unable to have a regular follow up for geographical, social or psychological reasons.
研究组 & 干预措施
Blood sampling
干预措施: Blood sampling (Procedure)
结局指标
主要结局
Specificity of plasma circulating tumor DNA detection as a test to detect any (local or distant) relapse in patients who have been curatively treated for HPV-induced invasive pelvic cancer (cervix, anal canal, vagina, vulva, penis).
时间窗: up to 36 months
Specificity= % of patients with number of copies/ml of ctDNA \< threshold among those who don't experience a relapse within the 6 months after the blood draw (+14 days)
Sensitivity of plasma circulating tumor DNA detection as a test to detect any (local or distant) relapse in patients who have been curatively treated for HPV-induced invasive pelvic cancer (cervix, anal canal, vagina, vulva, penis).
时间窗: up to 36 months
Sensitivity= % of patients with number of copies/ml of ctDNA \> threshold among those who experience a relapse within 6 months (+14 days) after the blood draw.
次要结局
- Negative predictive values of ctDNA.(up to 36 months)
- Positive predictive values of ctDNA.(up to 36 months)