Unspecified Adult Solid Tumor, Protocol SpecificNCT00992303
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
An observational study of Unspecified Adult Solid Tumor, Protocol Specific, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- biologic sample preservation procedure, medical chart review and questionnaire administration
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Sarah Neufeld, 214-645-8525
About this study
Official title: Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients 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
Read the 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.
- Being tested
- biologic sample preservation procedure, medical chart review, questionnaire administration
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
medical chart reviewOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (5)
Local recurrence
To document local recurrence by treatment regimen and disease site.
Measured: 5 years
Distant metastasis
To document distant metastasis by treatment regimen and disease site.
Measured: 5 years
Overall survival
To document overall survival by treatment regimen and disease site.
Measured: 5 years
Toxicity by treatment regimen
To document toxicity by treatment regimen and disease site.
Measured: 1 year
Establishment of a prospective registry/database
To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Timmerman, University of Texas Southwestern Medical Center
- Investigators
- Robert Timmerman, MD, Principal investigator, University of Texas Southwestern Medical Center - Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992303
- Sponsor's protocol ID
- STU 072010-098
- Other IDs
- SCCC-032009-049, CDR0000653406
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2009
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes