Chemotherapy Resistance and Sensitivity Testing in Lung Tumors
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Purpose
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.
| Condition |
|---|
|
Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Chemotherapy Resistance and Sensitivity Testing in Lung Tumors |
- 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: | 500 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
suspected or confirmed diagnosis of lung cancer
- undergoing a fine needle aspiration, core biopsy, or excisional biopsy for diagnosis.
- Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
- Patient must be at least 18 years of age
- Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.
Exclusion Criteria:
- Patient pathology shows benign pathology for sample submitted
- Patient is not indicated to receive chemotherapy for their disease
Contacts and Locations| Contact: Pier P. Claudio, M.D., Ph.D. | 304-696-3516 | claudiop@marshall.edu |
| United States, West Virginia | |
| Cabell Huntington Hospital | Recruiting |
| Huntington, West Virginia, United States, 25701 | |
| Contact: Rajesh Sehgal, M.D. 304-399-6551 rajesh.sehgal@chhi.org | |
| Sub-Investigator: Rajesh Sehgal, M.D. | |
| Sub-Investigator: Michael V. Korona, M.D. | |
| Principal Investigator: | Pier P. Claudio, M.D., Ph. D | Marshall University School of Medicine |
More Information
No publications provided
| Responsible Party: | Pier Paolo Claudio, M.D., Ph.D., Associate Professor of Biochemistry and Microbiology, Marshall University |
| ClinicalTrials.gov Identifier: | NCT01570855 History of Changes |
| Other Study ID Numbers: | 246601-1 |
| Study First Received: | March 19, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Marshall University:
|
Lung cancer chemosensitivity |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013