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临床试验/NCT04702321
NCT04702321招募中不适用

Genetic Risks for Childhood Cancer Complications in Switzerland

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
6,000
试验地点
1
主要终点
Genetic variants in participants as a possible marker of risk of complications after childhood cancer

研究概览

简要总结

The objectives of the GECCOS project are to identify genetic variants associated with complications of childhood cancer using genotype-phenotype association studies. Germline genetic samples and data of the "Germline DNA Biobank for Childhood Cancer and Blood Disorders Switzerland" (BISKIDS) which is included in the Geneva Biobank for Hematology and Oncology in Pediatrics (BaHOP) will be used with clinical data of Swiss childhood cancer patients collected at the Institute of Social and Preventive Medicine in Bern.

详细描述

Background and rationale :

Around 300 children and adolescents are diagnosed with cancer each year in Switzerland. A wide range of acute and chronic complications have been linked to cancer and its treatments. Cancer treatments, though highly curative, have a high incidence of adverse events, not only acutely but also chronically. Depending on the type and dose of treatments, the complications vary. There are important inter-individual differences in the type and severity of complications associated with similar cancer treatments. Genetic variation was identified to affect some complications and is suspected to play an important role in many of these differences.

The GECCOS project on analysis of genetic risks for complications associated with childhood cancers fills the gap to analyze germline genetic data with clinical information on short- and long-term complications. This has not been done on a nationwide scale in Switzerland yet. The GECCOS project will improve knowledge on germline genetic risks for complications and further personalize care during acute treatment and follow-up of childhood cancer patients.

Objectives:

Primary objectives:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Registered in the Swiss Childhood Cancer Registry (SCCR) since 1976; AND
  • consented to the BaHOP (host biobank for the BISKIDS Biobanking project); AND
  • diagnosed with cancer according to the International Classification of Childhood Cancer, version 3, ICCC-3, or Langerhans cell histiocytosis (LCH) before age 21 years.

排除标准

  • Lacking written consent signed by participant and/ or their legal representative to participate in the BaHOP (where applicable); OR
  • died after study participation and declined use of their samples and data after their death in the original consent for BaHOP (as indicated on the BaHOP consent).

结局指标

主要结局

Genetic variants in participants as a possible marker of risk of complications after childhood cancer

时间窗: Genetic sequencing performed at enrollment into study

Genotyping of germline genetic variants (candidate gene, whole exome, or whole genome sequencing data)

次要结局

  • Number of participants with complications of childhood cancers: specific organ dysfunctions assessed by objective measurements and second primary neoplasms, extracted from medical records and cancer registry information(Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years)
  • Demographic and clinical covariates corresponding to possible risk factors for specific complications after childhood cancer, extracted from medical records and cancer registry information(Data collection at enrollment into study, and longitudinal data collection until last follow-up or death from any cause, approx. 10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Ansari

Professor Marc Ansari

University Hospital, Geneva

研究点 (1)

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