Chemotherapy Resistance and Sensitivity Testing in Lung Tumors

Completed

• Conditions: Lung Cancer

• Registration Number: NCT01570855
• Lead Sponsor: Marshall University

Brief Summary

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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Primary Completion: 2014-05
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor size	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.

Trial Locations

Locations (1)

Cabell Huntington Hospital; 🇺🇸 Huntington, West Virginia, United States