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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Neoplasms; Carcinoma Non-small-cell Lung
• Intervention / Treatment: Genetic: Multifocal Tissue Banking

Detailed Description

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
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mayo Clinic Rochester Patients

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Marie Christine Aubry, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2016
• Primary Completion (Actual): November 16, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: genetic; multifocal; next generation sequencing; bronchoalveolar carcinoma; adenocarcinoma in situ; ground glass opacity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 15-007961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No