BostonGene-Integrated Genomic Registry (BIGR)

Malignancy Clinical Trial

Official title:

BostonGene-Integrated Genomic Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991922
• Other study ID #: BG-001
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: July 1, 2036

Study information

• Verified date: February 2024
• Source: BostonGene
• Contact: Nathan Fowler
• Phone: +1-617-658-4545
• Email: nathan.fowler[@]bostongene.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: July 1, 2036
• Est. primary completion date: July 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignancy
• Neoplasms

Locations

Country	Name	City	State
United States	BostonGene	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
BostonGene

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	association between major finding and outcome, Descriptive	associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing.	5 years
Secondary	Predictive probability	identify molecular findings associated with therapy.	5 years
Secondary	Clinical trials matching	identify and link registry subjects to future molecular-based clinical research	5 years