Non Small Cell Lung Cancer, NUT Carcinoma, Small Cell Lung Carcinoma
Conditions
Keywords
Non Small Cell Lung Cancer, Small Cell Lung Carcinoma, Genetics, Genomics, Young lung cancer
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.
Interventions
GENETICData 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)
Sponsors
Dana-Farber Cancer Institute
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactPasi A Janne, MD, PhD
Outcome results
None listed