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

University of Texas Southwestern Medical Center10,000 enrolled

Overview

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

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

10,000

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

biologic sample preservation procedureOTHER

medical chart reviewOTHER

questionnaire administrationOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Maintenance a Tissue Resource and Registry/Database

Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database

Time frame: 10 years

Secondary Outcomes

Local recurrence

To document local recurrence by treatment regimen and disease site.

Time frame: 5 years

Distant metastasis

To document distant metastasis by treatment regimen and disease site.

Time frame: 5 years

Overall survival

To document overall survival by treatment regimen and disease site.

Time frame: 5 years

Toxicity by treatment regimen

To document toxicity by treatment regimen and disease site.

Time frame: 1 year

Establishment of a prospective registry/database

To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.

Time frame: 10 years

Central Contacts

Suprabha Pulipparacharuvil

CONTACT

214-645-8525 suprabha.pulipparacharuvil@utsouthwestern.edu

Data from ClinicalTrials.gov

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