Understanding inherited risk factors for lung cancer
Investigating Hereditary Risk In Thoracic Cancers (INHERIT)
This study is trying to understand how genetic factors affect the risk of lung cancer in people with little tobacco exposure, especially those with family histories of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05587439 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the genetic susceptibility to lung cancer, particularly among individuals with minimal tobacco exposure. It focuses on patients and families with known pathogenic germline mutations or significant family histories of lung cancer. Participants will be identified through multi-gene panel testing and personal cancer histories, allowing researchers to follow these individuals to better understand their risk and the natural history of lung cancer. The ultimate goal is to inform screening practices based on inherited risk factors.
Who should consider this trial
Good fit: Ideal candidates include individuals with known germline mutations related to lung cancer or those with strong family histories of the disease.
Not a fit: Patients without a family history of lung cancer or known genetic predispositions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and prevention strategies for lung cancer in genetically susceptible individuals.
How similar studies have performed: Other studies have shown promise in understanding genetic predispositions to various cancers, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cohort 1: individuals with or with high risk of carrying an EGFR T790M or other EGFR germline variant identified in blood or saliva, including via somatic single or multi-gene panel testing (MGPT). This includes both probands and family members. * Participants with variants of uncertain significance may be eligible at the PI's discretion * Cohort 2: individuals with or with high risk of carrying non-EGFR germline variants suggestive of a potential inherited lung cancer risk, identified in blood or saliva, including via somatic single or multi-gene panel testing (MGPT). This includes both probands and family members. * Participants with variants of uncertain significance may be eligible at the PI's discretion * Cohort 3: individuals with lung cancer who are not known to carry a pathogenic or likely pathogenic variant, and with one of the following: * first-degree relative with lung cancer * multi-generational family history of lung cancer * personal history of multiple primary lung cancers or other neoplasms * multifocal lung cancer This includes both probands and their families. * For each cohort, the following applies: * May include blood relatives of individuals with the aforementioned variants or family history, who may be presumed obligate carriers or healthy controls * Deceased patients may be included in the study. Pathology specimens and public records, such as death certificates, may be used to confirm information. If medical records and/or pathology specimens are needed, consent will be obtained from the descendant's next-of-kin. Next-of-kin refers to the following hierarchy of relatives: spouse, offspring, parents, and siblings. (Any further use of "next-of-kin" in this protocol refers to this hierarchy). * Data and specimens from previously consented eligible individuals (under Dana-Farber IRB protocol #12-360) will also be deposited into the study database and specimen banks from other investigators as long as their consents permit sharing of specimens and data. It is estimated that approximately 150 individuals may qualify under these criteria. * Some of the variants identified initially through germline testing may ultimately be shown to not be germline but rather somatic mosaic (ACE or CHIP). These individuals will remain in the study cohort but will not be asked for ongoing questionnaire or repeat specimen donation Exclusion Criteria: * Individuals who decline to consent * Individuals who are unable to give consent or assent and are without a designated healthcare proxy
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jaclyn LoPiccolo, MD, PhD — Dana-Farber Cancer Institute
- Study coordinator: Jaclyn LoPiccolo, MD, PhD
- Email: Jaclyn_LoPiccolo@dfci.harvard.edu
- Phone: 617-632-6036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.