Immune and Genomic Markers in ALK+ NSCLC

Description

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

Study Overview

Study Details

Study overview

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)

Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)

Immune and Genomic Markers in ALK+ NSCLC

Condition
Anaplastic Lymphoma Kinase Gene Translocation
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Jessica J Lin, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2025-12-01