Chemotherapy Resistance and Sensitivity Testing in Lung Tumors

NCT ID: NCT01570855

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cabell Huntington Hospital

OTHER

Sponsor Role collaborator

Marshall University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pier Paolo Claudio, M.D., Ph.D.

Associate Professor of Biochemistry and Microbiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pier P. Claudio, M.D., Ph. D

Role: PRINCIPAL_INVESTIGATOR

Marshall University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cabell Huntington Hospital

Huntington, West Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

246601-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.