Investigating Hereditary Risk In Thoracic Cancers (INHERIT)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
The purpose of this research study is to learn more about the inherited risk for developing lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Individuals who decline to consent
Individuals who are unable to give consent or assent and are without a designated healthcare proxy
Trial population
Dana-Farber Cancer Institute (DFCI), DFCI affiliates, satellites, or other sites clinics
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Data and Specimen Collection
Genetic* Provide blood and/or saliva sample * Answer short questionnaires * Consider consenting to other optional parts of the research such as: * use stored tissue samples related to prior cancer treatment * Allow access to deceased relatives' medical records and stored specimens * Provide blood 1x per year for up to 5 years * Provide contact information of family members
Treatment groups
500 Participants
are divided into 3 treatment groupsGroup A: Germline EGFR Mutations1 intervention
Group B: Germline Non-EGFR Mutations1 intervention
Group C: Family History Or Multiple Primaries Or Multi-Focal Non-Small Cell Lung Cancer NSCLC1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of rare germline EGFR mutations
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
Time frame
3 years2
Prevalence of rare germline non-EGFR mutations
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
Time frame
3 years3
Prevalence of rare pathogenic or likely pathogenic germline variants in familial lung cancers
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
Time frame
3 years4
Prevalence of rare pathogenic or likely pathogenic germline variants in lung cancer patients with multiple primary cancers or multi-focal NSCLC
To determine prevalence of rare pathogenic or likely pathogenic germline variants in lung cancer patients with multiple primary cancers or multi-focal NSCLC
Time frame
3 yearsSecondary outcomes
1
Preliminary Assessment of History of Lung Cancers
To make a preliminary assessment of the natural history of lung cancers occurring in patients with germline EGFR mutations
Time frame
3 years2
Estimate of Prevalence of Lung Nodules
To generate an initial estimate of the prevalence of CT-detected lung nodules in individuals with germline EGFR mutations
Time frame
3 years3
Repository of Specimens and Data
Prospective registry of patients and families with hereditary or familial lung cancer to collect clinicopathologic information and biologic specimens.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov