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

The University of Texas System (UT)

Status: Enrolling

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Other: questionnaire administration; Other: biologic sample preservation procedure; Other: medical chart review

Study type: Observational

Funder types: Other

Identifiers

NCT00992303

CDR0000653406

SCCC-032009-049

STU 072010-098

Details and patient eligibility

About

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

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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