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:
University of Texas Southwestern Medical Center
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
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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) |
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
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 25, 2012 |
| 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 May 23, 2013