Biology of Young Lung Cancer Study: The YOUNG LUNG Study

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05265429

Collaborator

(none)

500

Enrollment

Locations

Anticipated Duration (Months)

125

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer Small Cell Lung Carcinoma	Genetic: Data and Specimen Collection

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Biology of Young Lung Cancer Study: The YOUNG LUNG Study

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Data/Biospecimen 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	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)

Arm

Intervention/Treatment

Data/Biospecimen 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

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)

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
3	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
4	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115