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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

Tracking Information
First Submitted Date October 8, 2009
First Posted Date October 9, 2009
Last Update Posted Date April 23, 2018
Study Start Date September 2009
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2012)
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
Original Primary Outcome Measures
 (submitted: October 8, 2009)
Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database
Change History Complete list of historical versions of study NCT00992303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 25, 2012)
  • Disease outcome [ Time Frame: 5 years ]
    local recurrence, distant metastasis, overall survival by treatment regimen and disease site
  • Toxicity by treatment regimen and disease site [ Time Frame: 1 year ]
    by treatment regimen and disease site
  • Establishment of a prospective registry/database [ Time Frame: 10 years ]
    consisting of patient demographics and outcomes to be used for future research
Original Secondary Outcome Measures
 (submitted: October 8, 2009)
  • Disease outcome (local recurrence, distant metastasis, overall survival) by treatment regimen and disease site
  • Toxicity by treatment regimen and disease site
  • Establishment of a prospective registry/database consisting of patient demographics and outcomes to be used for future research
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy
Official Title Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients
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.

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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cancer patients
Condition Unspecified Adult Solid Tumor, Protocol Specific
Intervention
  • Other: biologic sample preservation procedure
  • Other: medical chart review
  • Other: questionnaire administration
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 25, 2012)
10000
Original Enrollment Not Provided
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00992303
Other Study ID Numbers STU 072010-098
SCCC-032009-049
CDR0000653406
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor University of Texas Southwestern Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Hak Choy, MD University of Texas Southwestern Medical Center - Dallas
PRS Account University of Texas Southwestern Medical Center
Verification Date April 2018