Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy

This study is currently recruiting participants.
Verified October 2009 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00992303
First received: October 8, 2009
Last updated: July 25, 2012
Last verified: October 2009

October 8, 2009
July 25, 2012
September 2009
December 2020   (final data collection date for primary outcome measure)
Maintenance a Tissue Resource and Registry/Database [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database
Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00992303 on ClinicalTrials.gov Archive Site
  • Disease outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    local recurrence, distant metastasis, overall survival by treatment regimen and disease site
  • Toxicity by treatment regimen and disease site [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    by treatment regimen and disease site
  • Establishment of a prospective registry/database [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    consisting of patient demographics and outcomes to be used for future research
  • Disease outcome (local recurrence, distant metastasis, overall survival) by treatment regimen and disease site [ Designated as safety issue: No ]
  • Toxicity by treatment regimen and disease site [ Designated as safety issue: No ]
  • Establishment of a prospective registry/database consisting of patient demographics and outcomes to be used for future research [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy
Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

Cancer patients

Unspecified Adult Solid Tumor, Protocol Specific
  • Other: biologic sample preservation procedure
  • Other: medical chart review
  • Other: questionnaire administration
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
December 2020
December 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT00992303
CDR0000653406, SCCC-032009-049, IRB# 8843
Yes
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Hak Choy, MD University of Texas Southwestern Medical Center - Dallas
University of Texas Southwestern Medical Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP