Pharmacogenomic Study in Patients of Lung, Colorectal and Head/Neck Cancers Receiving Chemotherapy

November 23, 2016 updated by: University of Kansas Medical Center

The purpose of this study is to look at several genes that might determine how the body processes the drugs used to treat lung, colorectal and head and neck cancers. The goal of this examination is to help investigators determine the proper dosage to give future cancer patients or to better predict which future patients will respond to particular drug therapies.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is to establish a pilot pharmacogenomic program in identifying genetic variation to predict the safety, toxicity and/or efficacy of drugs. DNA will be extracted from patients' peripheral blood to study SNPs in DPD, TS, MTHFR, UGT1A1, CYP3A4, CYP3A5, GSTM1, GSTT1, GSTP1, HO-1, ERCC1, XPD, XRCC1 and EGFR genes. The results of genetic study will be compared to treatment efficacy and toxicity. The ultimate goal is to use genotype profiles to provide individualized cancer treatment to improve outcome and decrease toxicity.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Kansas
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

medical center

Description

Inclusion Criteria:

Lung, Colorectal and Head and Neck Cancer Patients that have received or plan to receive chemotherapy as part of their treatment

Exclusion Criteria:

Colorectal cancer patients that have never received or will not receive chemotherapy as part of their therapy
Head and Neck cancer patients that have never received or will not receive chemotherapy as part of their treatment
Patients with cancer types other than colorectal or head and neck
Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
2 colorectal cancer patients
3 head and neck cancer patients
1 lung cancer patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Paul J. Patton Trust

Investigators

Principal Investigator: Yu-Jui Yvonne Wan, Ph.D., University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)