Immune and Genomic Markers in ALK+ NSCLC
Purpose
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)
Conditions
- Anaplastic Lymphoma Kinase Gene Translocation
- Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Sample Collection | 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. |
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.