RecruitingPhase not listed

Investigating Hereditary Risk In Thoracic Cancers (INHERIT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The research study procedures include screening for eligibility, collection of information from participants' medical record, short questionnaires, and collecting blood and/or saliva samples."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how gene changes passed down in families may raise the risk of lung cancer. It is for people with certain gene changes or signs of inherited lung cancer risk, and their families.

The purpose of this research study is to learn more about the inherited risk for developing lung cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You may qualify for one of the groups below. Family members may also qualify.
  • You have, or have a high chance of carrying, an inherited change in the EGFR gene, such as T790M, found through blood or saliva testing.
  • You have, or have a high chance of carrying, an inherited change in another gene that may raise lung cancer risk, found through blood or saliva testing.
  • If the meaning of your gene change is unclear, the lead study doctor may decide you can join.
  • You have lung cancer and no known harmful or likely harmful inherited gene change, plus at least one of these: a parent, sibling, or child with lung cancer; lung cancer across family generations; more than one separate lung cancer or other tumors; or lung cancer in several spots.
  • Blood relatives may join, including those believed to carry a gene change and healthy relatives used for comparison.
  • People who have died may be included. Permission from their closest family member is needed if medical records or tissue samples are needed.
  • Data and samples from eligible people who previously agreed to join Dana-Farber study #12-360 may be included if their consent allows sharing.

Who can't join

  • You do not agree to take part.
  • You cannot give consent or assent (agreement to join) and have no designated person who can make health care decisions for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (2)

MA