A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/26/2018 |
| Start Date: | February 2016 |
| End Date: | August 2019 |
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.
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.
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.
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:
- 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.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-538-1960
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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