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Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy

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ClinicalTrials.gov Identifier: NCT00992303
Recruitment Status : Recruiting
First Posted : October 9, 2009
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.


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

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.


Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients
Study Start Date : September 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022



Primary Outcome Measures :
  1. Maintenance a Tissue Resource and Registry/Database [ Time Frame: 10 years ]
    Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database


Secondary Outcome Measures :
  1. Disease outcome [ Time Frame: 5 years ]
    local recurrence, distant metastasis, overall survival by treatment regimen and disease site

  2. Toxicity by treatment regimen and disease site [ Time Frame: 1 year ]
    by treatment regimen and disease site

  3. Establishment of a prospective registry/database [ Time Frame: 10 years ]
    consisting of patient demographics and outcomes to be used for future research



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00992303     History of Changes
Other Study ID Numbers: STU 072010-098
SCCC-032009-049
CDR0000653406
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

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