Understanding inherited risk factors for lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.