Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT00992303
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2009-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2009-10-08', 'studyFirstSubmitQcDate': '2009-10-08', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintenance a Tissue Resource and Registry/Database', 'timeFrame': '10 years', 'description': 'Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database'}], 'secondaryOutcomes': [{'measure': 'Local recurrence', 'timeFrame': '5 years', 'description': 'To document local recurrence by treatment regimen and disease site.'}, {'measure': 'Distant metastasis', 'timeFrame': '5 years', 'description': 'To document distant metastasis by treatment regimen and disease site.'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'To document overall survival by treatment regimen and disease site.'}, {'measure': 'Toxicity by treatment regimen', 'timeFrame': '1 year', 'description': 'To document toxicity by treatment regimen and disease site.'}, {'measure': 'Establishment of a prospective registry/database', 'timeFrame': '10 years', 'description': 'To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* To document disease outcome (local recurrence, distant metastasis, overall survival) by treatment regimen and disease site.\n* To document toxicity by treatment regimen and disease site.\n* To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.\n\nOUTLINE: 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.\n\nPatients are followed up every 6 months for the first two years following treatment and then yearly thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients, healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Pathologically-proven diagnosis of malignancy\n* Planning treatment with radiation therapy\n\nPATIENT CHARACTERISTICS:\n\n* Able to perform follow-up visits\n* Is a patient of the University of Texas Southwestern Medical Center physicians\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Participation in other clinical trials is allowed\n* Other prior or concurrent therapy for cancer, such as surgery and/or chemotherapy, is allowed.\n\nCriteria for eligibility:\n\n* Able to provide written informed consent\n* Age greater than 18 years old\n* Males and Females are eligible\n* Any ethnicity is eligible\n\nCriteria for ineligibility:\n\n-Patients not available for follow-up/future contact'}, 'identificationModule': {'nctId': 'NCT00992303', 'briefTitle': 'Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants', 'orgStudyIdInfo': {'id': 'STU 072010-098'}, 'secondaryIdInfos': [{'id': 'SCCC-032009-049'}, {'id': 'CDR0000653406'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'biologic sample preservation procedure', 'type': 'OTHER'}, {'name': 'medical chart review', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Neufeld', 'role': 'CONTACT', 'phone': '214-645-8525'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Suprabha Pulipparacharuvil', 'role': 'CONTACT', 'email': 'suprabha.pulipparacharuvil@utsouthwestern.edu', 'phone': '214-645-8525'}], 'overallOfficials': [{'name': 'Robert Timmerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center - Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Timmerman', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}