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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.
This research study looks to enroll as many people diagnosed with lung cancer at 45 years old or younger in order to:
Study procedures will include:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data and Specimen Collection | Genetic |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults age 45 or under at time of non-small lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pasi A Janne, MD, PhD | Contact | 617-632-6036 | Pasi_Janne@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pasi A Janne, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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whole blood, serum, tissue
|
| 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 |
| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
|
| Brigham and Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |