NCT00992303

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Sep 2009Dec 2029

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
20.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

20.3 years

First QC Date

October 8, 2009

Last Update Submit

May 8, 2025

Conditions

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Maintenance a Tissue Resource and Registry/Database

    Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database

    10 years

Secondary Outcomes (5)

  • Local recurrence

    5 years

  • Distant metastasis

    5 years

  • Overall survival

    5 years

  • Toxicity by treatment regimen

    1 year

  • Establishment of a prospective registry/database

    10 years

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients, healthy volunteers

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Study Officials

  • Robert Timmerman, MD

    University of Texas Southwestern Medical Center - Dallas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Study Start

September 1, 2009

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations