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Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Maintenance a Tissue Resource and Registry/Database

Outcome Description:

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

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Hak Choy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center - Dallas

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000653406

NCT ID:

NCT00992303

Start Date:

September 2009

Completion Date:

December 2020

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Ut Southwestern Medical CenterDallas, Texas  75390