Chemotherapy Resistance and Sensitivity Testing in Lung Tumors

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Cabell Huntington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor size	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.	3 months

Collaborators and Investigators

• Sponsor: Marshall University
• Collaborators: Cabell Huntington Hospital
• Investigators: Principal Investigator: Pier P. Claudio, M.D., Ph. D, Marshall University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: April 2, 2012
• First Posted (Estimate): April 4, 2012

Study Record Updates

• Last Update Posted (Estimate): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Lung cancer; chemosensitivity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 246601-1