BostonGene-Integrated Genomic Registry (BIGR)
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|ClinicalTrials.gov Identifier: NCT04991922|
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : August 5, 2021
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||100000 participants|
|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|
- 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.
- Predictive probability [ Time Frame: 5 years ]identify molecular findings associated with therapy.
- Clinical trials matching [ Time Frame: 5 years ]identify and link registry subjects to future molecular-based clinical research
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
|Contact: Nathan Fowlerfirstname.lastname@example.org|
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02453|
|Contact: Krystle Nomie, PhD 617-658-4545 email@example.com|
|Principal Investigator:||Nathan Fowler||BostonGene|