Clinical trial NCT02705404: A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing
Official title: A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Neoplasms
Carcinoma Non-small-cell Lung
Keywords: multifocal
genetic
bronchoalveolar carcinoma
adenocarcinoma in situ
ground glass opacity
next generation sequencing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic Rochester Patients

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Marie Christine Aubry, MD
role: PRINCIPAL_INVESTIGATOR
References: