Investigating Hereditary Risk In Thoracic Cancers (INHERIT)

This study, called INHERIT, aims to understand more about how inherited genes can increase the risk of developing lung cancer, especially in people who haven't smoked much. Researchers will collect blood and/or saliva samples and ask you to fill out short questionnaires. They are looking for specific genetic changes (biomarkers like EGFR mutations) in your genes that might be linked to lung cancer. The study will measure how common these genetic changes are over three years. You might be able to join if you are 18 or older and have certain genetic changes (like EGFR T790M) or a strong family history of lung cancer. The study is currently unclear about its recruitment status.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to enroll 500 participants.
What's involved
You would provide blood and/or saliva samples and answer short questionnaires. You might also consent to using stored tissue samples or allowing access to deceased relatives' medical records.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as the prevalence of certain genetic mutations, will be measured at 3 years.

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NCT05587439

Investigating Hereditary Risk In Thoracic Cancers (INHERIT)

Recruiting
Not specifiedAges 18+Observational
Dana-Farber Cancer Institute
~500 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Data and Specimen Collection

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of rare germline EGFR mutations
Measured over 3 years
+3 more outcomes measured
Lung Cancer
Genetic Disease
Genetic Predisposition
Hereditary Diseases
2 sites across 1 states
Massachusetts2
  • Jaclyn LoPiccolo, MD, PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

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Eligibility criteria

Inclusion

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

Individuals who decline to consent
Individuals who are unable to give consent or assent and are without a designated healthcare proxy
  • Prevalence of rare germline EGFR mutations3 years

    To determine the prevalence of rare germline EGFR T790M or other (e.g., EGFR V843I and R776H) mutations in lung cancer patients and in relatives of carriers of germline EGFR mutations

  • Prevalence of rare germline non-EGFR mutations3 years

    To determine the prevalence of rare germline non-EGFR mutations (e.g., HER2, BRCA2, MET, YAP1) in lung cancer patients and in relatives of carriers of germline non-EGFR mutations

  • Prevalence of rare pathogenic or likely pathogenic germline variants in familial lung cancers3 years

    To determine prevalence of rare pathogenic or likely pathogenic germline variants in individuals and families where lung cancer has occurred in multiple generations or across multiple family members of the same generation

  • Prevalence of rare pathogenic or likely pathogenic germline variants in lung cancer patients with multiple primary cancers or multi-focal NSCLC3 years

    To determine prevalence of rare pathogenic or likely pathogenic germline variants in lung cancer patients with multiple primary cancers or multi-focal NSCLC