NCT06907095招募中不适用
A Prospective Cohort to Evaluate the Ability of Different Body fLuid-derived Approaches to Detect EArly-stage Cancers Among High-risk Individuals
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,909
- 试验地点
- 1
- 主要终点
- sensitivity of techniques derived from body fluids in the detection of any invasive cancer
研究概览
简要总结
LEAH is a prospective, observational, single-centre, non-randomised, open-label study of people at increased risk of cancer or malignant disease.
The main objective of LEAH is to evaluate and compare the sensitivity of different tests on body fluids to detect cancers that will occur within 3 years of inclusion in the study, in a cohort of individuals identified as being at increased risk of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •increased risk cohort:
- •Are aged 18 or more
- •Have a cumulative 3-year risk of developing any cancer ≥ 4% (including the situation specific cancers + other cancers) defined as follows:
- •Situations at increased risk of breast cancer
- •Women carrying germline pathogenic (P) or likely pathogenic (LP) variants of BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 genes without prophylactic mastectomy, aged ≥ 40 years, or
- •Men with germline (P) or (LP) variants in the BRCA2 gene, aged ≥ 40 years, or
- •Women with a personal history of an histological atypical breast lesion in the past 5 years and aged ≥ 50 years, or
- •Women with a personal history of unilateral breast cancer (including ductal carcinoma in situ) diagnosed more than 5 years before inclusion, and currently aged ≥ 60 years, or
- •Women who received chest radiotherapy before age 30 years and currently aged ≥ 25 years, or
- •Women with an invasive breast cancer risk > 2.5% over the next 5 years, as defined by risk scores +/- genotyping, and aged ≥ 50 years, or
- •Individuals identified at increased risk in MyPeBS trial (> 2.5% over the next five years) (www.mypebs.eu) can be eligible for the study, if aged ≥ 50 years, or
- •Situations at increased risk of gynaecological cancer
- •Women with a Lynch syndrome - germline (P) or (LP) variants in hMLH1, MSH2, hMLH6, PMS2, and aged ≥ 30 years, or
- •Women carrying germline (P) or (LP) variants of BRCA1, BRCA2, PALB2, RAD51C or RAD51D, PTEN genes without prophylactic oophorectomy, aged ≥ 40 years, or POLE and POLD1, and aged > 30 years; or SMARCA4 or DICER1 and aged > 18 years or
- •Situations at increased risk of colorectal cancer
- •Men or women with a Lynch syndrome - germline (P) or (LP) variants in hMLH1, MSH2, hMLH6, PMS2, APC, POLE, POLD1, BMPR1A, SMAD4 or biallelic MuTYH genes, and aged ≥ 40 years, or
- •Individuals with an increased risk of colorectal cancer defined by the following criteria and aged ≥ 50 years, or
- •First-degree relative diagnosed with colorectal cancer before the age of 60 years, or
- •Two or more 1st degree relatives diagnosed with colorectal cancers at any age, or
- •Personal history of any colorectal adenoma before the age of 50 years or adenomatous polyps > 1 cm, villous adenomas, dysplastic adenomas, or ≥ 3 adenomatous polyps after the age of 50 years, or
- •Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) after the age of 50 years, or
- •Situations at increased risk of upper gastrointestinal cancers
- •Carriers of an STK11 or CDH1 germline (P) or (LP) variants and aged > 30, or
- •Individuals with an increased risk of esophageal adenocarcinoma: Barrett's esophagus with high-grade dysplasia, or
- •Situations at increased risk of hepatic cancers
- •- Individuals at increased risk of hepatocellular carcinoma because of documented liver fibrosis or cirrhosis (whether secondary to non-alcoholic steatohepatitis, alcohol-related, or virus-related), or
- •Situations at increased risk for pancreatic cancers
- •Patients with a family history with > 2 pancreatic cancers in close relatives and aged >50 or
- •Chronic pancreatitis and aged >50 or carriers of PRSS1 or SPINK1 germline (P) or (LP) variants or
- •Patients at increased risk of pancreatic cancer based on a composite score or
- •Carriers of CDKN2A germline (P) or (LP) variants or
- •Carriers of germine (P) or (LP) variants in BRCA2, ATM, BRCA1, PALB2, or Lynch syndrome-associated gene alterations with a first-degree or multiple family history of pancreatic ductal carcinoma (PDAC) or
- •Patients with a Peutz-Jeghers syndrome (STK11 germline (P) or (LP) variants) or
- •Situations at increased risk of lung cancer
- •- History of heavy smoking > 20 pack-years among active or previous smokers who have quitted up to 10 years ago, and aged ≥ 50 years, or
- •Situations at increased risk of skin cancers except basal-cell carcinomas
- •Carriers of germline (P) or (LP) variants in CDKN2A/CDK4 or BAP1 genes, aged ≥ 50 years or
- •Carriers of germline (P) or (LP) variants of genes that predispose to skin cancers (Xeroderma pigmentosum, etc…) or
- •Situations at increased risk of head and neck cancers
- •Individuals with high-grade dysplasia or carcinoma in situ of the upper aero digestive tract within the last 10 years, and aged ≥ 50 years, or
- •Individuals with oral lichen planus diagnosed more than 10 years ago, and aged ≥ 50 years or
- •Previous history of a head and neck cancer in complete remission for ≥ 5 years, aged ≥ 50 years, and at least one of the following criteria:
- •Current or former smoker > 10 pack-years Current or former alcohol consumption > 14 units/week
- •Situations at increased risk of mesothelioma
- •- Individuals with a history of relevant professional exposure to asbestos, and/or germline (P) or (LP) variants in BAP1, and aged ≥ 50 years, or
- •Situations at increased risk of kidney cancer
- •- Carriers of germline (P) or (LP) variants in the BAP1, VHL, FH, cMET, FLCN, SDH-B genes, and aged ≥ 50 years, or
- •Situations at increased risk of prostate cancer
- •Men aged ≥ 40 year with any of the following:
- •Strong family history: a first- or second-degree relative with metastatic prostate cancer, ovarian cancer, male breast cancer, female breast cancer aged ≤ 45 years, colorectal or endometrial cancer aged ≤ 50 years, pancreatic cancer or two or more first- or second-degree relatives with breast, prostate (but not clinically localized grade group 1), colorectal or endometrial cancer at any age, or
- 另有 37 项未显示
排除标准
- •Known prior diagnosis of cancer or hematological malignancy within the past 5 years except for non-melanoma skin cancers, in situ cervical cancers and for patients with germline TP53 alterations,
- •Presence of signs or symptoms of cancer at enrolment,
- •Acute exacerbation of an autoimmune condition requiring escalation in medical therapy within 14 days prior to enrolment,
- •Any medical condition with a high likelihood of mortality within three years,
- •Physical or psychological conditions considered not to be compatible with the study and not likely to comply with follow up requirements,
- •Individuals under guardianship or deprived of their liberty by a judicial or administrative decision or incapable of giving their consent,
- •Women carriers of (P) or (LP) variants in BRCA1, BRCA2, PALB2, gene considering prophylactic mastectomy in a near future or aged less than 40 years (since their absolute risk of cancer is lower than the expected threshold)
- •Received a blood transfusion within the last week before inclusion.
研究组 & 干预措施
individuals at low risk of invasive cancer
Active Comparator
A cohort of individuals who are not considered at increased risk (low risk) of cancer seen in consultation for a problem defined as benign will also be recruited and be used for certain secondary and exploratory objectives.
干预措施: biological samples (Diagnostic Test)
individuals at high risk of invasive cancer
Active Comparator
Individuals with an estimated risk ≥ 4% of occurrence of any invasive cancer or malignancy (except for basal cell carcinoma of the skin) in the following three years after inclusion will be proposed the trial. This 4% cumulative risk represents the addition of i. the participant's general risk of any cancer or malignancy based on her/his age and ii. her/his risk of a specific malignancy based on her/his risk profile.
干预措施: biological samples (Diagnostic Test)
结局指标
主要结局
sensitivity of techniques derived from body fluids in the detection of any invasive cancer
时间窗: baseline and In case of cancer within 3 years
The primary endpoint is the sensitivity of body fluid-derived techniques in the detection of any invasive cancer (except for non-melanoma skin cancers) in the 36 months period following body fluid collection among individuals at increased risk of cancer.
次要结局
- Evaluation of the 3-year early detection performance of techniques derived from body fluids(baseline and In case of cancer within 3 years)
- Evaluation in terms of predicting the risk of developing invasive cancer of the added value at 3 years of body fluid-derived techniques and their various combinations compared with standard baseline factors(baseline and In case of cancer within 3 years)
- Assessment of the ability of body fluid-derived techniques to identify the tissue of origin by agreement between the location predicted by the body fluid-derived techniques and the tissue of origin.(baseline and In case of cancer within 3 years)
研究者
研究点 (1)
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