Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Other: biologic sample preservation procedure
Other: medical chart review
Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 10000
Study Start Date: September 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992303

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Jean Wu, MSN    214-645-8525      
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Hak Choy, MD University of Texas Southwestern Medical Center - Dallas
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00992303     History of Changes
Other Study ID Numbers: CDR0000653406, SCCC-032009-049, IRB# 8843
Study First Received: October 8, 2009
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on August 28, 2014