Lynch Syndrome Integrative Epidemiology and Genetics (LINEAGE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Colorectal cancer incidence
研究概览
简要总结
The vision of the "Lynch syndrome INtegrative Epidemiology And GEnetics" (LINEAGE) Consortium is to collaboratively improve the lives and longevity of individuals and families with Lynch syndrome.
The mission of the LINEAGE Consortium is to collaboratively improve Lynch syndrome care through high-quality research. This consortium will provide intellectual and infrastructure support to facilitate development of research questions, collection of standardized data and biospecimens, support of grant applications, and generation of collaborative manuscripts.
Our aims are to:
I. Establish a prospective cohort of individuals with Lynch syndrome II. Collect standardized longitudinal clinical and biosample data to elucidate Lynch Syndrome epidemiology and gene-host interactions III. Promote intervention trials to improve cancer prevention and early detection in Lynch Syndrome
详细描述
The main objective of this consortium is to build a shared resource to drive research in critical areas necessary to understand LS-related neoplasia risk and improve early detection and prevention of LS-associated cancers. This consortium will provide intellectual and infrastructure support to facilitate development of research questions, collection of standardized clinical data and biospecimens, support grant applications, and generate collaborative manuscripts.
Data and samples collected for LINEAGE will allow the consortium to address a variety of topic areas including but not limited to:
I. Risk of prevalent and incident colorectal neoplasia among PV/LPV carriers. II. Estimate risk of prevalent and incident extra-colonic neoplasm among PV/LPV carriers.
III. Characterization of post-colonoscopy colorectal cancer among PV/LPV carriers.
IV. Risk factors for prevalent and incident neoplasia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •• Adults age over 18 years
- •Eligible patients must have at least one variant of uncertain significance (VUS), pathogenic or likely pathogenic variant (PV/LPV) in MLH1, MSH2, MSH6, PMS2, or EPCAM, which will be confirmed by genetic testing results (obtained as part of routine care) and a review of the variant in ClinVar (https://www.ncbi.nlm.nih.gov/clinvar/).
- •Individuals who are an obligate carrier of a LS PV/LPV that is confirmed in the family.
排除标准
- •Age under 18
结局指标
主要结局
Colorectal cancer incidence
时间窗: 40 years
cases of adenocarcinoma of the colon or rectum diagnosed over the observation period
次要结局
- non-colorectal cancer incidence(40 years)
- precancerous colorectal polyps(40 years)
研究者
Swati Patel
Associate Professor
University of Colorado, Denver