Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants

July 15, 2026 updated by: Robert Timmerman, University of Texas Southwestern Medical Center

Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants

RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting tissue samples from patients with cancer undergoing radiation therapy. Healthy participants will also be allowed on the trial so their samples can be used in comparison to patients with malignancy

Study Overview

Status

Recruiting

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

To maintain and create a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database that will be used to explore genetic variations contributing to clinical outcomes through tissue analysis and outcome correlation. Tissue will be stored by the UTSTR and the database managed by Radiation Oncology.

Secondary

To document disease outcome (local recurrence, distant metastasis, overall survival) by treatment regimen and disease site.
To document toxicity by treatment regimen and disease site.
To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.

OUTLINE: Tissue, including surgical waste, venous blood/serum, urine, bone marrow, and other body fluids, may be collected (at planned surgery and routine medical visits) and preserved for future research. Demographic and disease and treatment information is obtained from patients (by interview or questionnaire), from medical records, and from national datasets. Patients may also be asked to provide additional blood samples and/or a small skin-punch biopsy sample.

Patients are followed up every 6 months for the first two years following treatment and then yearly thereafter.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

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

Study Contact

Name: Suprabha Pulipparacharuvil
Phone Number: 214-645-8525
Email: suprabha.pulipparacharuvil@utsouthwestern.edu

Study Locations

United States
- Texas
  - Dallas, Texas, United States, 75390
    - Recruiting
    - UT Southwestern Medical Center
    - Contact:
      
      Sarah Neufeld
      
      Phone Number: 214-645-8525

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Cancer patients, healthy volunteers

Description

DISEASE CHARACTERISTICS:

Pathologically-proven diagnosis of malignancy
Planning treatment with radiation therapy

PATIENT CHARACTERISTICS:

Able to perform follow-up visits
Is a patient of the University of Texas Southwestern Medical Center physicians

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Participation in other clinical trials is allowed
Other prior or concurrent therapy for cancer, such as surgery and/or chemotherapy, is allowed.

Criteria for eligibility:

Able to provide written informed consent
Age greater than 18 years old
Males and Females are eligible
Any ethnicity is eligible

Criteria for ineligibility:

-Patients not available for follow-up/future contact

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance a Tissue Resource and Registry/Database Time Frame: 10 years	Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence Time Frame: 5 years	To document local recurrence by treatment regimen and disease site.	5 years
Distant metastasis Time Frame: 5 years	To document distant metastasis by treatment regimen and disease site.	5 years
Overall survival Time Frame: 5 years	To document overall survival by treatment regimen and disease site.	5 years
Toxicity by treatment regimen Time Frame: 1 year	To document toxicity by treatment regimen and disease site.	1 year
Establishment of a prospective registry/database Time Frame: 10 years	To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.	10 years

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Investigators

Principal Investigator: Robert Timmerman, MD, University of Texas Southwestern Medical Center - Dallas

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

September 1, 2009

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)