Status:
ACTIVE_NOT_RECRUITING
Immune and Genomic Markers in ALK+ NSCLC
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
LUNGevity Foundation
Addario Lung Cancer Medical Institute
Conditions:
Anaplastic Lymphoma Kinase Gene Translocation
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this research study is to obtain and study clinical history, and tissue and saliva specimens if available from participants with Anaplastic Lymphoma Kinase-ALK+ Non-Small Lung Cancer(NS...
Detailed Description
The purpose of this study is to establish a registry of clinical data and tumor specimens of patients with advanced ALK+ non-small lung cancer (NSCLC) (defined as NSCLC harboring an ALK gene rearrange...
Eligibility Criteria
Inclusion
- Cohort 1 - Alive Individuals
- Men or women 18 years of age or the age of majority for their residential state of the United States, or older, at the time of consent.
- Histologically or cytologically confirmed advanced stage IIIB-IIIC not amenable to curative approach multi-modality (e.g., chemoradiation and/or surgery) treatment, or stage IV non-small cell lung cancer (NSCLC)
- Demonstration of having advanced ALK+ NSCLC, as assessed by fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), next-generation sequencing (NGS) or circulating tumor DNA analysis (ctDNA). For ALK FISH, fusions must have been detected in at least 15% of tumor cells.
- Willingness to provide clinical and medical information to the study team as required.
- Willingness to provide archival tumor tissue, if available. Patients may enroll even if no tumor tissue is available.
- Ability to read, write and communicate in English.
- Ability to sign a web-based informed consent form.
- Cohort 2 - Deceased Individuals
- Deceased individuals diagnosed with advanced ALK+ lung cancer at age 18 years or older may be studied on a case by case basis. Inclusion will require availability of adequate archived tissue and release of tissue and records by next of kin, if available.
Exclusion
- Participants who are unwilling to provide informed consent.
- Participants who are younger than 18 years of age.
- Participants who are unable to comply with the study procedures.
- Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
- Participants who have previously enrolled to the study.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04881916
Start Date
December 1 2021
End Date
July 1 2027
Last Update
August 15 2025
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114