Clinical trial · Observational
Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer
Genomics of Young Lung Cancer Study
NCT02273336CI-TRIAL-00055100completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research trial studies genomic analysis in tissue and blood samples from young patients with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid \[DNA\]) may help doctors tailor treatment to target the specific mutations and help plan effective treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (comprehensive genomic analysis)
- description
- Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
- interventionNames
- Other: cytology specimen collection procedure
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Prevalence of targetable mutations, defined as any alteration in a drive oncogene for which Food and Drug Administration-approved therapy exists, for which an off-label therapy exists, or for which a clinical trial exists
- timeFrame
- Baseline
- description
- Will compare this population with the historical experience of the Lung Cancer Mutation Consortium. For this specific comparison, the prevalence of mutations in EGFR, ALK, v-raf murine sarcoma viral oncogene homolog B1 (BRAF), human epidermal growth factor receptor 2 (HER2), v-ros avian UR2 sarcoma virus oncogene homolog 1 (ROS1), and met proto-oncogene (MET) will be calculated.
- measure
- Proportion of young lung cancer patients that enroll onto clinical trials
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: * COHORT 1: LUNG CANCER PATIENTS * Pathologically confirmed bronchogenic lung carcinoma (small cell lung cancer \[SCLC\] or non-small cell lung cancer \[NSCLC\] of any stage) at any treatment time point * For individuals diagnosed with advanced disease (stage IV or recurrent) enrollment must occur within 2 years of diagnosis * For appropriate patients (stage IV non-squamous NSCLC) epidermal growth factor receptor (EGFR ) and anaplastic lymphoma kinase (ALK) genotyping performed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is recommended prior to participation * Provision of written informed consent * Willingness to undergo a single blood draw * Individuals who are under 18 are eligible for study if they meet the defined criteria for cohort 1; in addition, consent for participation must be given by a legal guardian or parent * NOTE: to be eligible for genomics, availability of 10 unstained slides (plus hematoxylin and eosin \[H\&E\] slide) or an adequate formalin-fixed paraffin-embedded (FFPE) tumor block from clinically indicated interventional procedures is required * COHORT 2: DECEASED INDIVIDUALS * Deceased individuals diagnosed with lung cancer at any age less than 40 may be studied on a case by case basis depending upon Institutional Review Board (IRB) approval at a participating institution; inclusion will require availability of adequate archived FFPE tissue and release of tissue and records by next of kin, if available Exclusion Criteria: * Compromise of patient diagnosis or staging if tissue is used for research
References
Publications (0)
Data not yet available
No reference posted for this study.