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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.)
Sponsor:
Collaborator:
Cabell Huntington Hospital
Information provided by (Responsible Party):
Pier Paolo Claudio, M.D., Ph.D., Marshall University
ClinicalTrials.gov Identifier:
NCT01570855
First received: March 19, 2012
Last updated: April 2, 2014
Last verified: April 2014
  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 Marshall University:

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: 500
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

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

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: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Marshall University:
Lung cancer
chemosensitivity

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014