NCT05587439 Investigating Hereditary Risk In Thoracic Cancers (INHERIT)
| NCT ID | NCT05587439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-01-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to learn more about the inherited risk for developing lung cancer.
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
Contact & Investigator
Jaclyn LoPiccolo, MD, PhD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT05587439 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05587439 currently recruiting?
Yes, NCT05587439 is actively recruiting participants. Contact the research team at Jaclyn_LoPiccolo@dfci.harvard.edu for enrollment information.
Where is the NCT05587439 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT05587439 clinical trial?
NCT05587439 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Jaclyn LoPiccolo, MD, PhD at Dana-Farber Cancer Institute. The trial plans to enroll 500 participants.
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