BostonGene-Integrated Genomic Registry (BIGR)

Recruiting

• Conditions: Malignancy

• Registration Number: NCT04991922
• Lead Sponsor: BostonGene

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2031-07-01
• Study Completion: 2036-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

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

Exclusion Criteria

Life expectancy < 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
association between major finding and outcome, Descriptive	5 years	associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing.

Secondary Outcome Measures

Name	Time	Method
Predictive probability	5 years	identify molecular findings associated with therapy.
Clinical trials matching	5 years	identify and link registry subjects to future molecular-based clinical research

Trial Locations

Locations (1)

BostonGene; 🇺🇸 Waltham, Massachusetts, United States