BostonGene-Integrated Genomic Registry (BIGR)

NCT ID: NCT04991922

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2036-07-01

Brief Summary

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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

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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.

Conditions

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Malignancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BostonGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Fowler

Role: PRINCIPAL_INVESTIGATOR

BostonGene

Locations

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BostonGene

Waltham, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nathan Fowler

Role: CONTACT

+1-617-658-4545

Facility Contacts

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Krystle Nomie, PhD

Role: primary

617-658-4545

References

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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.

Reference Type BACKGROUND
PMID: 32467593 (View on PubMed)

Sambi 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.

Reference Type BACKGROUND
PMID: 30941175 (View on PubMed)

Olivier 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.

Reference Type BACKGROUND
PMID: 31561483 (View on PubMed)

Other Identifiers

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BG-001

Identifier Type: -

Identifier Source: org_study_id

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