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Chemotherapy Resistance and Sensitivity Testing in Lung Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570855
First Posted: April 4, 2012
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cabell Huntington Hospital
Information provided by (Responsible Party):
Pier Paolo Claudio, M.D., Ph.D., Marshall University
  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

Resource links provided by NLM:


Further study details as provided by Pier Paolo Claudio, M.D., Ph.D., Marshall University:

Primary Outcome Measures:
  • Tumor size [ Time Frame: 3 months ]

    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.



Enrollment: 45
Study Start Date: October 2011
Study Completion Date: December 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570855


Locations
United States, West Virginia
Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
Marshall University
Cabell Huntington Hospital
Investigators
Principal Investigator: Pier P. Claudio, M.D., Ph. D Marshall University School of Medicine
  More Information

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
First Submitted: March 19, 2012
First Posted: April 4, 2012
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Pier Paolo Claudio, M.D., Ph.D., Marshall University:
Lung cancer
chemosensitivity