Recruitment

Recruitment Status
Enrolling by invitation

Inclusion Criteria

PFT's and other clinical determinates that show the subject is capable of tolerating a lung biopsy or resection.
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.
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.
Subject must be > 18 years of age
Subject must be able to understand and willing to sign an IRB-approved informed consent document.
Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.

Summary

Conditions
  • Carcinoma Non-small-cell Lung
  • Lung Neoplasms
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Inclusion Criteria

PFT's and other clinical determinates that show the subject is capable of tolerating a lung biopsy or resection.
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.
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.
Subject must be > 18 years of age
Subject must be able to understand and willing to sign an IRB-approved informed consent document.
Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.

Locations

Rochester, Minnesota, 55905
Rochester, Minnesota, 55905

Tracking Information

NCT #
NCT02705404
Collaborators
Not Provided
Investigators
  • Principal Investigator: Marie Christine Aubry, MD Mayo Clinic
  • Marie Christine Aubry, MD Mayo Clinic