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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
Sponsor:
Information provided by (Responsible Party):
Marie Christine Aubry, Mayo Clinic

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.

Condition or disease Intervention/treatment
Lung Neoplasms Carcinoma Non-small-cell Lung 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  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. [ 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mayo Clinic Rochester Patients
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Marie Christine Aubry, MD Mayo Clinic

Additional Information:
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Responsible Party: Marie Christine Aubry, MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02705404     History of Changes
Other Study ID Numbers: 15-007961
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marie Christine Aubry, Mayo Clinic:
multifocal
genetic
bronchoalveolar carcinoma
adenocarcinoma in situ
ground glass opacity
next generation sequencing
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases