A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing
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|ClinicalTrials.gov Identifier: NCT02705404|
Recruitment Status : Enrolling by invitation
First Posted : March 10, 2016
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment|
|Lung Neoplasms Carcinoma Non-small-cell Lung||Genetic: Multifocal Tissue Banking|
A frequent clinical dilemma in lung cancer care is the management of multifocal lung cancers. The management decision is based on determining if multiple cancers represent true independent primary cancers or related metastasis. This determination is critical to the appropriate staging of the cancers and treatment. Indeed, this distinction represents the difference between aggressive local therapy with either surgery or radiation therapy for primary early stage lesions, or palliative chemotherapy or best supportive care with appropriate symptom management for advanced stage metastatic disease.
No existing pathologic or molecular test is currently capable of making the distinction between multiple independent lung primaries from metastatic disease with accuracy. The recent release of preliminary data from the NLST screening trial, suggesting survival benefit for screening high risk patients with CT scanning, will only increase the number of patients facing these treatment dilemmas. The research team has recently developed a test that allows this distinction with great accuracy. This test allows determination of lineage between two tumors using the identification of large genomic rearrangements using mate pair next generation sequencing (MP). The test has been developed using fresh frozen tissue from resected lung tumors and is currently being validated for a clinical test.
The investigators' goal is to develop the test using cytology and small biopsy specimens.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||50 Years|
|Official Title:||A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||August 2020|
- Feasibility measured by being able to gather small samples from patients and having enough tissue to get results from the mate pair next generation sequencing. [ Time Frame: 1 year ]Performance of the mate pair next generation sequencing lineage test on cytology and small biopsy specimens obtained as part of routine clinical practice, through either a bronchoscopic, CT-guided needle procedure, or lung resection as evidenced in receiving results from the sequencing.
Biospecimen Retention: Samples With DNA
The patient will have some or all of the samples taken listed below:
- Blood sample of 10 ml (2 teaspoons).
- Up to two lung bronchoscopic or transbronchoscopic needle aspiration biopsies will be given to the research study during an already scheduled bronchoscopy. In addition at the time of the bronchoscopy a brushing or washing specimen could be collected for research.
- A piece of lung or lymph node tissue taken at the time of the CT guided lung or lymph node biopsy will be given to the research study.
- A piece of lung tumor tissue removed during surgery will be given to the research study.
- If pleural fluid is removed as part of the procedure(s) and there is any fluid left after what is needed for your clinical care, it will be given to the research study.
- DNA genome sequencing will be performed on the collected tissues, blood and fluid.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705404
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Marie Christine Aubry, MD||Mayo Clinic|