Clinical trial NCT00992303: Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
Official title: Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients, healthy volunteers

Brief summary: 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

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.

Eligibility 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

Primary outcomes:
measure: Maintenance a Tissue Resource and Registry/Database
timeFrame: 10 years
Secondary outcomes:
measure: Local recurrence
timeFrame: 5 years
measure: Distant metastasis
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Toxicity by treatment regimen
timeFrame: 1 year
measure: Establishment of a prospective registry/database
timeFrame: 10 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center - Dallas
name: Robert Timmerman, MD
role: PRINCIPAL_INVESTIGATOR
References: