MalignancyNCT04991922
BostonGene-Integrated Genomic Registry (BIGR)
An observational study of Malignancy, run by BostonGene at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Jul 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Life expectancy < 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
BostonGene
Waltham, Massachusetts, 02453
Nathan Fowler, MD, +17815523131, nathan.fowler@bostongene.com
About this study
Official title: BostonGene-Integrated Genomic Registry Study
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
Read the 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.
- Conditions
- Malignancy
- Keywords
- cancer, precision medicine, WES, RNA-seq, immuno-therapy, genomic, transcriptomic, multiomic
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
association between major finding and outcome, Descriptive
associations between genomic findings and outcomes of cancer patients who have undergone comprehensive sequencing.
Measured: 5 years
Secondary outcomes (2)
Predictive probability
identify molecular findings associated with therapy.
Measured: 5 years
Clinical trials matching
identify and link registry subjects to future molecular-based clinical research
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BostonGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan Fowler, Principal investigator, BostonGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991922
- Sponsor's protocol ID
- BG-001
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32467593Sambi 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.
PubMed 30941175Olivier 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.
PubMed 31561483
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BostonGene-Integrated Genomic Registry Study
- ClinicalTrials.gov ID
- NCT04991922
- Acronym / sponsor ID
- BG-001
- Conditions
- Malignancy
- Keywords
- cancer, precision medicine, WES, RNA-seq, immuno-therapy, genomic, transcriptomic, multiomic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- BostonGeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- 1 Jul 2036 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Life expectancy < 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Predictive probability
Time frame: 5 years
Clinical trials matching
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 32467593Murciano-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.
- Background: PubMed 30941175Sambi 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.
- Background: PubMed 31561483Olivier 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Fowler principal investigator
BostonGene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignancy, run by BostonGene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Fowler, MD (+17815523131, nathan.fowler@bostongene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between major finding and outcome, Descriptive (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991922, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.