Biology of Young Lung Cancer Study: The YOUNG LUNG Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biology of Young Lung Cancer Study: The YOUNG LUNG Study

Conditions
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Non Small Cell Lung Cancer, Small Cell Lung Carcinoma

Intervention / Treatment
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* Genetic: Data and Specimen Collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Data/Biospecimen Collection<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genomics, Non Small Cell Lung Cancer, Small Cell Lung Carcinoma, Genetics, Young lung cancer