Chemotherapy Resistance and Sensitivity Testing in Lung Tumors

Lung Cancer Clinical Trial

Official title:

Chemotherapy Resistance and Sensitivity Testing in Lung Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570855
• Other study ID #: 246601-1
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: April 25, 2016
• Start date: October 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Marshall University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer

Locations

Country	Name	City	State
United States	Cabell Huntington Hospital	Huntington	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Marshall University	Cabell Huntington Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No