Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anaplastic Lymphoma Kinase Gene Translocation
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Registry Establishment
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Jessica Jiyeong Lin, M.D.
Principal Investigator
Massachusetts General Hospital
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.
Outcomes
Primary Outcomes
Registry Establishment
Time Frame: Up to 2 years
Establish a registry of clinical data and tumor specimens from goal of 100 patients with advanced ALK+ NSCLC (defined as NSCLC harboring an ALK gene rearrangement), for characterization of the immunophenotype and genomic landscape of ALK+ NSCLC.
Secondary Outcomes
- Overall survival (OS)(Up to 2 years)
- Duration Of Therapy(Up to 2 years)
- ALK resistance mutations(Up to 2 years)
- Tumor immunophenotype(Up to 2 years)
- Genomic alterations(Up to 2 years)