NCT05582122招募中2 期
SURVEILLE-HPV: National, Multicenter, Open-label, Randomized, Phase II Study Evaluating HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UNICANCER
- 入组人数
- 420
- 试验地点
- 16
- 主要终点
- Negative Predictive Value (NPV) of HPV16 ct-DNA
研究概览
简要总结
SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures.
HPV-positive oropharyngeal cancer patients have a much better prognosis that their HPV-negative counterparts. Despite this, Post Treatment Surveillance (PTS) strategy does not take into account HPV status.
HPV Circulating DNA (HPV Ct DNA) has emerged as a promising tool to assess the risk of cancer recurrence following treatment. We assume that this biomarker could be helpful to guide PTS.
The number of systematic PTS visits could be significantly reduced in patients with undetectable HPV Ct DNA whereas a closer clinical and radiological follow up could be performed in case of detectable HPV Ct DNA.
If confirmed, this new strategy could have several benefits including:
- reduction of PTS visits for most HPV-positive patients which implies a potential cost decrease and
- Identification of relapse at early stages (before the occurrence of symptoms)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient aged 18 years or over
- •Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)
- •Clinical stage T1-4, N0-3, M0 (stages I-III)
- •Any tobacco status
- •Life expectancy greater than 36 months
- •Positive HPV16 Ct-DNA measured before curative anticancer treatment
- •Treated by any curative treatment
- •Complete response at 3 months after end of treatment, which means:
- •Undetectable HPV16 Ct-DNA and no residual disease on imaging (group A) or
- •Undetectable HPV16 Ct-DNA and suspicious imaging but persistent disease excluded by either biopsy or repeated imaging (group B1) or
- •Positive HPV16 Ct-DNA and no residual disease on imaging but negative HPV16 Ct-DNA on the subsequent assessment. This second test will be done 1-2 months after the first one (group C1).
- •Patient must be affiliated to a Social Security System (or equivalent)
- •Patients must have signed a written informed consent form prior to any trial specific procedures. If the patient is physically unable to give his/her written consent, a trusted person of his/her choice, note related to the investigator or the sponsor, can confirm in writing the patient's consent.
排除标准
- •Uncontrolled intercurrent illness that would limit compliance with study requirements.
- •Active invasive malignancy within 3 years of inclusion except for non-invasive malignancies such as non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.
- •Any other HPV induced cancer within 5 years
- •Any condition that may jeopardize the patient participation as well as non-contraception for male and female with child-bearing potential, pregnancy or breast-feeding
- •Patient unwilling or unable to comply with the study protocol and follow-up schedule.
- •Participation in another clinical trial with an investigational medical product during the last 30 days prior to the inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product that have a marketed authorization, used as per the summary of product characteristics (SmPC) for the given indication).
- •Patient deprived of liberty or placed under protective custody or guardianship.
研究组 & 干预措施
Lightened follow-up visits frequency (9 visits over 5 years), with HPV16 Ct-DNA dosing
Experimental
Physical Examinations (with HPV16 Ct-DNA dosing) planned at Months 4,8,12,18,24,30,36,48,60 post treatment.
Annual chest CT scan will be performed for current smokers & for those who have quit smoking less than 15 years ago.
Any patient with a normal PE but positive HPV16 ct-DNA test during follow-up period will require a confirmation test ~1-2 months later.
If HPV16 ct-DNA positivity is confirmed, an H&N MRI /PET-CT will be performed. Then:
- If MRI and PET-CT are negative, the patient will be examined every 2 months (PE and HPV16 Ct-DNA dosing) and MRI/PET-CT will be repeated every 4-6 months, until HPV16 Ct-DNA becomes undetectable.
- If MRI and/or PET-CT is positive, the patient will get a biopsy to confirm disease recurrence. Once confirmed, the patient will have the necessary care, as per local practices, but will continue to be followed up within this study up to 5 years after treatment.
干预措施: HPV16 Ct-DNA dosing (Biological)
结局指标
主要结局
Negative Predictive Value (NPV) of HPV16 ct-DNA
时间窗: 24 months
The presence of HPV16 ct-DNA will be evaluated by ddPCR. NPV will be defined as 2 successive HPV16 ct-DNA negative results.
次要结局
- Rate of relapses detected by HPV16 ct-DNA(5.5 years)
- Overall survival(From randomization to death from any cause, up to 5.5 years)
- Loco-Regional recurrence(From randomization to disease recurrence, up to 5.5 years)
- Time of distant recurrence(From randomization to disease recurrence, up to 5.5 years)
- 5- year Negative Predictive Value(48 and 60 months)
- Positive Predictive Value (PPV) of HPV16 ct-DNA(18, 24, 48, and 60 months)
- Disease-free survival(5.5 years)
- Cost-effectiveness analysis of the proposed strategy(5.5 years)
研究者
研究点 (16)
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