Biology of Young Lung Cancer Study: The YOUNG LUNG Study

Non Small Cell Lung Cancer Clinical Trial

Official title:

Biology of Young Lung Cancer Study: The YOUNG LUNG Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265429
• Other study ID #: 21-442
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: October 2023
• Source: Dana-Farber Cancer Institute
• Contact: Pasi A Janne, MD, PhD
• Phone: 617-632-6036
• Email: Pasi_Janne[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Genetic:
• Data and Specimen Collection
Provide research team access to relevant medical records Answer two (2) short questionnaires at time of consent Provide up to 5 tubes (37 ml) of blood at or near the time of consent, and/or saliva sample Consider consenting to other optional parts of the research such as: Providing additional blood or tissue samples in the future (optional) Providing permission for obtainment of stored tissue specimens from lung cancer surgeries or biopsies from the pathology departments where they have been stored (optional)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repository of specimens and data	Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.	5 years or study closure
Secondary	Number of patients with targetable somatic alterations in known oncogenic driver genes	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.	5 years or study closure
Secondary	Number of patients with predicted oncogenic alterations in unknown driver genes	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.	5 years or study closure
Secondary	Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes	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.	5 years or study closure