ACTIVE_NOT_RECRUITING

Immune and Genomic Markers in ALK+ NSCLC

Conditions

Anaplastic Lymphoma Kinase Gene Translocation Non-Small Cell Lung Cancer ALK

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2021-12-01

Study Completion:2027-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04881916

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Jessica J Lin, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Jessica J Lin, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01

Study Completion Date2027-07-01

Study Record Updates

Study Start Date2021-12-01

Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

Anaplastic Lymphoma Kinase Gene Translocation
Non-Small Cell Lung Cancer
ALK

Additional Relevant MeSH Terms

Anaplastic Lymphoma Kinase Gene Translocation
Non-Small Cell Lung Cancer