Biology of Young Lung Cancer Study: The YOUNG LUNG Study

Recruiting

• Conditions: Non Small Cell Lung Cancer; Small Cell Lung Carcinoma; NUT Carcinoma
• Interventions: Genetic: Data and Specimen Collection

• Registration Number: NCT05265429
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.

Detailed Description

This research study looks to enroll as many people diagnosed with lung cancer at 45 years old or younger in order to:

* Better understand causes of lung cancer in individuals 45 years old and younger, which is a rare disease

* Better estimate lung cancer risks and potential risk factors for lung cancer in individuals 45 years old and younger

* Examine tumor (somatic) or normal (germline) genetic changes that may be shared among young lung cancer patients

* Improve opportunities for screening and treatment of lung cancer in individuals 45 years old and younger

Study procedures will include:

* Collecting information from participants' medical record and two (2) short questionnaires

* Collecting blood and/or saliva samples

* Collecting tumor tissue samples (optional)

It is expected that about 500 people will take part in this research study. Participants will be in this study until it closes or the participant withdraws consent.

Study Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Study Start: 2023-01-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age 45 and under at lung cancer diagnosis
• Pathologically confirmed bronchogenic lung carcinoma (NSCLC or SCLC of any stage) at any treatment time point
• Provision of written informed consent
• Willingness to undergo no more than two (2) peripheral blood draws in a four (4) week period, with no more than 50 ml peripheral blood collected over eight (8) weeks
• Individuals under age 18 are eligible for study if they meet defined criteria; in addition, consent for participation must be given by a legal guardian or parent

Exclusion Criteria

• Individuals who decline to sign consent
• Individuals who are unable to give consent or assent and are without a designated healthcare proxy
• Compromise of patient diagnosis or staging if tissue is used for research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Data/Biospecimen Collection	Data and Specimen Collection	Tumor and saliva specimens from participants with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosed at age 45 or younger

Primary Outcome Measures

Name	Time	Method
Repository of specimens and data	5 years or study closure	Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.

Secondary Outcome Measures

Name	Time	Method
Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes	5 years or study closure	Pathogenic or likely pathogenic variants based on classification by the American College of Medical Genetics and Genomics (ACMG). Results will be summarized using descriptive statistics.
Number of patients with targetable somatic alterations in known oncogenic driver genes	5 years or study closure	Targetable alterations are defined as any somatic alteration in a driver oncogene for which a Food and Drug Administration-approved therapy exists, for which an off-label therapy exists, or for which a clinical trial exists (including but not limited to EGFR, KRAS, ALK, ROS1, RET, MET, BRAF, and TRK). Results will be summarized using descriptive statistics.
Number of patients with predicted oncogenic alterations in unknown driver genes	5 years or study closure	Unknown driver genes include genes not currently known to be driver oncogenes in lung cancer, and for which no directed treatment exists. Results will be summarized using descriptive statistics.

Trial Locations

Locations (4)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States