RECRUITING

Investigating Hereditary Risk In Thoracic Cancers (INHERIT)

Conditions

Lung Cancer Genetic Disease Genetic Predisposition Hereditary Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Investigating Hereditary Risk In Thoracic Cancers (INHERIT)

Quick Facts

Study Start:2023-01-01

Study Completion:2027-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05587439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* Individuals who decline to consent * Individuals who are unable to give consent or assent and are without a designated healthcare proxy

Inclusion Criteria

Exclusion 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

* Individuals who decline to consent
* Individuals who are unable to give consent or assent and are without a designated healthcare proxy

Contacts and Locations

Study Contact

Pasi A Jänne, MD, PhD

CONTACT

617-632-6036

Pasi_Janne@dfci.harvard.edu

Jaclyn LoPiccolo, MD, PhD

CONTACT

617-632-6036

Jaclyn_LoPiccolo@dfci.harvard.edu

Principal Investigator

Pasi A Jänne, MD, PhD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Pasi A Jänne, MD, PhD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01

Study Completion Date2027-11-01

Study Record Updates

Study Start Date2023-01-01

Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

Lung Cancer
Genetic Disease
Genetic Predisposition
Hereditary Diseases

Additional Relevant MeSH Terms

Lung Cancer
Genetic Disease
Genetic Predisposition
Hereditary Diseases