A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing

NCT02705404 | Terminated

• 1 other identifier: 15-007961
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are doing this research to see if they can use small tissue samples or fluid to develop a test that will determine if the tissue samples are related or not related to each other. The test will use the patient's DNA, which is part of their unique genetic material that carries the instructions for the body's development and function. Cancer can result from changes in a person's genetic material that causes cells to divide in an uncontrolled way and, sometimes, to travel to other organs. Currently, researchers and doctors know some of the genetic changes that can cause cancer, but they do not know all of the genetic changes that can cause cancer.

Conditions

Lung Neoplasms; Carcinoma Non-small-cell Lung

Keywords

multifocal; genetic; bronchoalveolar carcinoma; adenocarcinoma in situ; ground glass opacity; next generation sequencing

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 year

Interventions

Multifocal Tissue Banking GENETIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mayo Clinic Rochester Patients

You may qualify if:

• Subject must be \> 18 years of age
• Presumed or known lung cancer.
• Undergoing bronchoscopy, CT guided lung biopsy, or lung resection as part of their clinical care at the Mayo Clinic Rochester.
• PFT's and other clinical determinates that show the subject is capable of tolerating a lung biopsy or resection.
• Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.
• Subject must be able to understand and willing to sign an IRB-approved informed consent document.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

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.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar; Adenocarcinoma in Situ

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Christine Aubry, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 10, 2016
• Study Start: February 11, 2016
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)