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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00992303
• Other study ID #: STU 072010-098
• Secondary ID: SCCC-032009-049C
• Status: Recruiting
• Start date: September 2009
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Sarah Hardee, MS
• Phone: 214-645-8525
• Email: sarah.hardee[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• biologic sample preservation procedure

• medical chart review

• questionnaire administration

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Local recurrence	To document local recurrence by treatment regimen and disease site.	5 years
Secondary	Distant metastasis	To document distant metastasis by treatment regimen and disease site.	5 years
Secondary	Overall survival	To document overall survival by treatment regimen and disease site.	5 years
Secondary	Toxicity by treatment regimen	To document toxicity by treatment regimen and disease site.	1 year
Secondary	Establishment of a prospective registry/database	To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.	10 years