Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants

NCT ID: NCT00992303

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2029-12-31

Brief Summary

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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. Healthy participants will also be allowed on the trial so their samples can be used in comparison to patients with malignancy

Detailed Description

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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.

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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biologic sample preservation procedure

Intervention Type OTHER

medical chart review

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any ethnicity is eligible

Criteria for ineligibility:

-Patients not available for follow-up/future contact
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Robert Timmerman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Timmerman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center - Dallas

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Suprabha Pulipparacharuvil

Role: CONTACT

214-645-8525

Facility Contacts

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Sarah Neufeld

Role: primary

214-645-8525

Other Identifiers

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SCCC-032009-049

Identifier Type: -

Identifier Source: secondary_id

CDR0000653406

Identifier Type: -

Identifier Source: secondary_id

STU 072010-098

Identifier Type: -

Identifier Source: org_study_id

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