Brief Title
Immune and Genomic Markers in ALK+ NSCLC
Official Title
Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)
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(NSCLC)
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 rearrangement). This will allow in-depth, comprehensive genomic and immunophenotypic analyses of ALK+ tumors. Together with the clinical data, these biologic specimens will enable the conduct of basic and translational research to identify genomic and immunologic markers associated with clinical outcomes for ALK+ patients.
Study Type
Observational [Patient Registry]
Primary Outcome
Registry Establishment
Secondary Outcome
Duration Of Therapy
Condition
Anaplastic Lymphoma Kinase Gene Translocation
Study Arms / Comparison Groups
Sample Collection
Description: Participation In: Initial data completion: Telephone collection of information on disease, treatment and testing Medical record collection: Collection of medical records regarding cancer, testing, and treatment history Archival tissue collection: Collection of tumor from prior standard of care procedure Saliva collection: Saliva collection with at home kit Follow up data completion: Telephone collection of medical condition every 3-6 months up to 2 years.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
100
Start Date
December 1, 2021
Completion Date
December 1, 2025
Primary Completion Date
December 1, 2025
Eligibility Criteria
Inclusion Criteria: 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 Criteria: - 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jessica J Lin, MD, 617-724-4000, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04881916
Organization ID
20-237
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Collaborators
Lungevity Foundation
Study Sponsor
Jessica J Lin, MD, Principal Investigator, Massachusetts General Hospital
Verification Date
January 2022