Immune and Genomic Markers in ALK+ NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2027-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarker Expression in Samples From Young Patients With Anaplastic Large Cell Lymphoma

NCT01366170

Lymphoma

COMPLETED

Tissue Microarrays (TMAs) Construction in Lung Cancer Samples

NCT03136523

Lung Cancer

COMPLETED

Study of Tissue Samples From Patients With Stage I Non-Small Cell Lung Cancer Enrolled on Research Study CALGB-140202

NCT00990873

Lung Cancer

COMPLETED

Microarray Analysis of Gene Expression and Identification of Progenitor Cells in Lung Carcinoma

NCT00568906

Carcinoma, Giant Cell Carcinoma, Non-Small-Cell Lung Lung Cancer

TERMINATED

Analysis of Biomarkers in Lymph Node Tissue

NCT04228796

Analysis of Biomarkers in Lymph Node Tissue

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anaplastic Lymphoma Kinase Gene Translocation Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No