Biology of Young Lung Cancer Study: The YOUNG LUNG Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorDana-Farber Cancer Institute
About this trial
The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults age 45 or under at time of non-small lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosis
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Data and Specimen Collection
Genetic* 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)
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Data/Biospecimen Collection1 intervention
Trial outcomes
Primary outcomes
1
Repository of specimens and data
Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.
Time frame
5 years or study closureSecondary outcomes
1
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.
Time frame
5 years or study closure2
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.
Time frame
5 years or study closure3
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.
Time frame
5 years or study closureSponsors and contacts
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Source ClinicalTrials.gov