NCT06090214尚未招募不适用
Circulating Tumor Cells for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid : a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Number of circulating tumor cell
研究概览
简要总结
The role of this transversal study is to assess the specificity and sensitivity of liquid biopsy to detect circulating cells tumor of adenocarcinoma of the ethmoid.
Blood sample of participants will be collected at the moment of the surgical procedure or recurrence diagnosis; immediately after surgery; at day 8-10; at month 2-3 of postoperative follow-up.
Two comparison groups will be studied: one age and gender-matched group and one professional exposure-matched group to assess the sensitivity and specificity of liquid biopsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Case group: diagnosis of adenocarcinoma of the ethmoid on biopsy or imaging recurence; age>/= 18 years; patient consent ;
- •Age and gender-matched control group: consulting patient in otolaryngology head and neck surgery department without adenocarcinoma of the ethmoid; no personal history of cancer; no familial history of colorectal adenocarcinoma;
- •Exposition control group: Professional exposition to wood dust, leaver or nickel for at least 12 months; consulting patient in otolaryngology head and neck surgery department without adenocarcinoma of the ethmoid; no personal history of cancer; no familial history of colorectal adenocarcinoma;
排除标准
- •patient presenting with another malignant tumor
- •deprivation of liberty
- •patient under guardianship
- •Other cancer diagnosed or under treatment
- •Recurrent patient previously included in the study
- •Refusal to accept the monitoring described and/or to provide the information required for the study
- •No affiliation or non-beneficiary of a Social Security system;
- •Pregnant or breast-feeding women in accordance with article L1121-5 of the Public Health Code (CSP)
结局指标
主要结局
Number of circulating tumor cell
时间窗: Day0, Day 7 to 10, VMonth 3 for patients ; Day 0 for controls
Presence of at least 1 circulating tumor cell in the liquid biopsies
次要结局
- Tumor Node Metastasis (TNM) classification(Day 0)
- Tumor diagnosis(Day 0)
- Location of tumour site(Day 0)
- Number of postoperative circulating tumor cell release(At the surgery)
- Histological subtype(Day 0)
- Presence of Circulating Tumor Cells (CTCs) in at least one of the patient's peripheral samples(at the surgery, day7, month3)
- Estimated tumour volume(Day 0)
研究者
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