BostonGene-Integrated Genomic Registry (BIGR)
1 other identifier
observational
100,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 28, 2021
CompletedFirst Posted
Study publicly available on registry
August 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2036
February 7, 2024
February 1, 2024
10 years
July 28, 2021
February 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
association between major finding and outcome, Descriptive
associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing.
5 years
Secondary Outcomes (2)
Predictive probability
5 years
Clinical trials matching
5 years
Eligibility Criteria
Subjects will be identified for the BIGR study from a larger group of patients undergoing BostonGene clinical testing (e.g., BostonGene Tumor Portrait TestTM).
You may qualify if:
- 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
You may not qualify if:
- Life expectancy \< 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BostonGenelead
Study Sites (1)
BostonGene
Waltham, Massachusetts, 02453, United States
Related Publications (3)
Murciano-Goroff YR, Warner AB, Wolchok JD. The future of cancer immunotherapy: microenvironment-targeting combinations. Cell Res. 2020 Jun;30(6):507-519. doi: 10.1038/s41422-020-0337-2. Epub 2020 May 28.
PMID: 32467593BACKGROUNDSambi M, Bagheri L, Szewczuk MR. Current Challenges in Cancer Immunotherapy: Multimodal Approaches to Improve Efficacy and Patient Response Rates. J Oncol. 2019 Feb 28;2019:4508794. doi: 10.1155/2019/4508794. eCollection 2019.
PMID: 30941175BACKGROUNDOlivier M, Asmis R, Hawkins GA, Howard TD, Cox LA. The Need for Multi-Omics Biomarker Signatures in Precision Medicine. Int J Mol Sci. 2019 Sep 26;20(19):4781. doi: 10.3390/ijms20194781.
PMID: 31561483BACKGROUND
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Fowler
BostonGene
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2021
First Posted
August 5, 2021
Study Start
July 1, 2021
Primary Completion (Estimated)
July 1, 2031
Study Completion (Estimated)
July 1, 2036
Last Updated
February 7, 2024
Record last verified: 2024-02