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临床试验/NCT04991922
NCT04991922招募中不适用

BostonGene-Integrated Genomic Registry Study

BostonGene1 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100,000
试验地点
1
主要终点
association between major finding and outcome, Descriptive

研究概览

简要总结

The purpose of this project is to develop a comprehensive database of genomic, transcriptomic, molecular, and clinical characteristics of oncology patients to discover, define, and develop genomic and transcriptomic markers to improve future clinical outcomes across cancer types

详细描述

Immuno- and targeted therapies have shown promising results for many types of cancer (1). However, the effectiveness of these treatments is not optimal for many patients (2). Therefore, further research is needed to discover, define, and develop genomic, transcriptomic, and integrated molecular markers that can improve clinical outcomes across cancer types (3). Unfortunately, current research is restricted by the limited availability of genomic and transcriptomic results linked to clinical outcomes (3). This study will allow for the collection of key clinical data, including longitudinal follow-up, linked with individual genetic and molecular findings in a single comprehensive registry-based databank. Analysis of these data may lead to advances across cancer subtypes through the identification of transcriptomic and genomic associations with therapies.

Clinical and pathological information, including detailed genetic information from a participant's tumor biopsy, will be obtained by the research staff for each participant enrolled in the BIGR Study. Clinical information will include relevant details about the patient's diagnosis and treatment and will be stored in a secure electronic registry database. No extra scans or procedures for this study will be collected as part of this study. Information will be collected regarding a participant's initial diagnosis, treatment, and outcome. To obtain this information, study staff will contact participants or a participant's doctor at regular time intervals for up to 15 years.

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

入选标准

  • Suspected or confirmed malignancy
  • Planned comprehensive genomic (> 100 genes) and/or molecular analysis; or genomic and/or molecular data available from prior sequencing
  • Baseline demographics and treatment information available
  • Willingness for future contact by BIRG study personnel to provide information regarding associated cancer outcomes and treatment.
  • Signed informed consent to participate in the study.
  • Living in the United States at the time of enrollment

排除标准

  • Life expectancy < 3 months

结局指标

主要结局

association between major finding and outcome, Descriptive

时间窗: 5 years

associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing.

次要结局

  • Predictive probability(5 years)
  • Clinical trials matching(5 years)

研究者

发起方
BostonGene
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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