Chemotherapy Resistance and Sensitivity Testing in Lung Tumors
This study has suspended participant recruitment.
(lung cancer study was rolled into a broader "human subject tissue" study including lung cancer.)
Cabell Huntington Hospital
Information provided by (Responsible Party):
Pier Paolo Claudio, M.D., Ph.D., Marshall University
First received: March 19, 2012
Last updated: April 2, 2014
Last verified: April 2014
The purpose of this study is to screen chemotherapy drugs currently used to treat lung cancer and determine the most effective treatment based on results of chemo sensitivity testing on the patients own cancer cells in the laboratory. The results of this screening will not influence the patients treatment.
||Observational Model: Cohort
Time Perspective: Prospective
||Chemotherapy Resistance and Sensitivity Testing in Lung Tumors
Primary Outcome Measures:
- Tumor size [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Tumor response will be evaluated (progression/regression) by CT scan at 3 months from therapy start.
Clinical response to chemotherapy of lung cancer tumor cells versus lung cancer stem cells to standard of care chemo drugs will be evaluated and correlated to predicted drug by ex vivo assay.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
The chemosensitivity assay will be performed on tissue obtained during the diagnostic fine needle aspiration, core biopsy, or excisional biopsy of the lung lesion. Cancer cells (Bulk of tumor) and Cancer Stem Cells (CSCs) will be isolated and expanded in the laboratory.
The drug screening assay will be used to evaluate the response of the CSCs and of the cancer cells to the various chemotherapy regimens.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients who have a suspected or confirmed diagnosis of lung cancer, and who are scheduled to have a diagnostic fine needle aspiration, core needle biopsy, or excisional biopsy of the lung lesion.
- Patient pathology shows benign pathology for sample submitted
- Patient is not indicated to receive chemotherapy for their disease
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570855
|Cabell Huntington Hospital
|Huntington, West Virginia, United States, 25701 |
Cabell Huntington Hospital
||Pier P. Claudio, M.D., Ph. D
||Marshall University School of Medicine
No publications provided
||Pier Paolo Claudio, M.D., Ph.D., Associate Professor of Biochemistry and Microbiology, Marshall University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 19, 2012
||April 2, 2014
||United States: Institutional Review Board
Keywords provided by Marshall University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2014
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