Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients

The goal of this laboratory research study is to collect and analyze treatment, molecular profiling and biomarker data. The results of the data analysis will be used to better understand how to characterize tumors and identify therapies that may be tailored to individual patients and to identify and/or predict side effects that may occur and/or predict which therapies may be best for participants. Research may also be done on your existing tissue to identify new biomarkers.

Study Overview

• Status: Unknown
• Conditions: Advanced Cancers
• Intervention / Treatment: Other: Biomarker Research

Detailed Description

Molecular Profiling/Deep Sequencing:

Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor that might predict how the tumor responds to therapy. Deep sequencing is a more detailed type of molecular profile that allows for a more focused analysis of individual genes.

Biomarker Data:

A characteristic that is measured and evaluated as an indicator of normal biologic processes, disease processes or pharmacologic responses to a therapeutic intervention.

Study Participation:

If you agree to take part in this study, information from your medical record will be collected. The information that researchers will collect includes your medical history, chemotherapy schedule(s), as well as the results of any tests, procedures, and/or therapies you may have had. Your responses to the therapies, your side effects, and the results of any diagnostic tests performed during therapy will also be collected.

Researchers want to learn if they could have better predicted your response to therapy using the information collected in this study and/or better predict side effects from your treatment.

The data collected from your medical record will be stored in a password-protected database at MD Anderson to be used in research related to this study for up to 10 years.

In addition, research studies on new biomarkers may be conducted on your previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.

Your name, medical record number, and any other personal identifiable information collected from your medical record will be replaced with a code number. No identifying information will be directly linked to the data collected from your medical record. Only the doctor who is in charge of this study, and select members of their research staff, will have access to the code numbers and be able to link any of the data back to you.

Use of Samples:

Before your banked tissue samples can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your tissue samples from this bank, must first be approved by the IRB.

Your tissue samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Other researchers using your samples will not be able to link this data to you.

Length of Study:

Your participation in this study will be over after either the data, blood, tumor tissue samples, and/or archived tumor samples are analyzed.

This is an investigational study.

Up to 2000 participants will take part in this study. All will be enrolled at MD Anderson.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Filip Janku, MD, PHD; Phone Number: 713-563-1930; Email: fjanku@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Clinical Center for Targeted Therapy at UT MD Anderson Cancer Center in Houston, Texas

Description

Inclusion Criteria:

1. All patients referred to the Clinical Center for Targeted Therapy are potentially eligible for recruitment.

Exclusion Criteria:

n/a

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Biomarker/Molecular Data Collection and Analyzation; Advanced cancer participants	Other: Biomarker Research; Research studies on new biomarkers conducted on previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Biomarker Profiling to Treatment Outcome	For correlating marker profiles with response to treatment, univariate and multivariate (multiple covariates) logistic regression used, with response status taken as outcome variable. Distributions of time-to-event outcomes estimated using Kaplan-Meier curves, and these distributions compared among groups using log rank test.	2 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Filip Janku, MD, PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2010
• Primary Completion (Anticipated): September 27, 2020
• Study Completion (Anticipated): September 27, 2020

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Advanced Cancers; Molecular profiling; Tumor marker; Biomarker data; Data analysis
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LAB10-0441; 3UL1RR024148-04S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No