Immune and Genomic Markers in ALK+ NSCLC

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.

Estimated Enrollment

100

Start Date

July 2021

Completion Date

June 1, 2025

Primary Completion Date

June 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

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

May 2021