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BostonGene-Integrated Genomic Registry (BIGR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04991922
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
BostonGene

Study Description
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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

Condition or disease
Malignancy

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 Design
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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BostonGene-Integrated Genomic Registry Study
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : July 1, 2031
Estimated Study Completion Date : July 1, 2036
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. association between major finding and outcome, Descriptive [ Time Frame: 5 years ]
    associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing.


Secondary Outcome Measures :
  1. Predictive probability [ Time Frame: 5 years ]
    identify molecular findings associated with therapy.

  2. Clinical trials matching [ Time Frame: 5 years ]
    identify and link registry subjects to future molecular-based clinical research


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be identified for the BIGR study from a larger group of patients undergoing BostonGene clinical testing (e.g., BostonGene Tumor Portrait TestTM).
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04991922


Contacts
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Contact: Nathan Fowler +1-617-658-4545 nathan.fowler@bostongene.com

Locations
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United States, Massachusetts
BostonGene Recruiting
Waltham, Massachusetts, United States, 02453
Contact: Krystle Nomie, PhD    617-658-4545    krystle.nomie@bostongene.com   
Sponsors and Collaborators
BostonGene
Investigators
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Principal Investigator: Nathan Fowler BostonGene
More Information
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Publications:

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Responsible Party: BostonGene
ClinicalTrials.gov Identifier: NCT04991922    
Other Study ID Numbers: BG-001
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BostonGene:
cancer
precision medicine
WES
RNA-seq
 immuno-therapy
genomic
transcriptomic
multiomic
Additional relevant MeSH terms:
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Neoplasms