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Recruiting

NCT Number: NCT00992303

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Sarah Neufeld

CONTACT

214-645-8525

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Criteria for eligibility:

  • Able to provide written informed consent
  • Age greater than 18 years old
  • Males and Females are eligible
  • Any ethnicity is eligible

Criteria for ineligibility:

-Patients not available for follow-up/future contact

Treatment and study plan

biologic sample preservation procedure

Other

medical chart review

Other

Questionnaire Administration

Other

Primary outcomes

  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 outcomes

  1. Local recurrence

    Time frame: 5 years

    To document local recurrence by treatment regimen and disease site.

  2. Distant metastasis

    Time frame: 5 years

    To document distant metastasis by treatment regimen and disease site.

  3. Overall survival

    Time frame: 5 years

    To document overall survival by treatment regimen and disease site.

  4. Toxicity by treatment regimen

    Time frame: 1 year

    To document toxicity by treatment regimen and disease site.

  5. Establishment of a prospective registry/database

    Time frame: 10 years

    To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.

Study contacts

Contact information is provided by the study sponsor or research team.

Suprabha Pulipparacharuvil

CONTACT

[email protected]

214-645-8525

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants

Important dates

Study start
2009
Primary completion
2029
Study completion
2029
First posted
Oct 9, 2009
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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