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

ArmDescriptionAssigned 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

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Jessica J Lin, MD
617-724-4000
jjlin1@partners.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Jessica J Lin, MD
617-724-4000
jjlin1@partners.org

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.