BostonGene-Integrated Genomic Registry (BIGR)

Study Overview
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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.

Official Title
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BostonGene-Integrated Genomic Registry Study

Conditions
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Malignancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Life expectancy < 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| association between major finding and outcome, Descriptive | associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive probability | identify molecular findings associated with therapy. | 5 years | 
| Clinical trials matching | identify and link registry subjects to future molecular-based clinical research | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WES, cancer, precision medicine, RNA-seq, immuno-therapy, genomic, transcriptomic, multiomic