Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 8:46 AM
Study NCT ID:
NCT00512551
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2007-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Array Analysis of Patients With Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Two biopsies of the cervix will be performed to obtain tumor cells.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2007-08-03', 'studyFirstSubmitQcDate': '2007-08-03', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation.', 'timeFrame': '8 Years'}], 'secondaryOutcomes': [{'measure': 'Researchers will study a large number of genes located in tumor material to learn this information.', 'timeFrame': '8 Years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical Cancer', 'DNA Array Analysis', 'Gene Expression', 'DNA'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'The University of Texas M.D.Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation. Researchers will study a large number of genes located in tumor material to learn this information.', 'detailedDescription': 'Patients in this study are already scheduled to begin radiation therapy. Researchers will get tumor cells by taking two biopsies of the cervix. The first biopsy of the cervical tumor will be done before any treatment is given. The second biopsy will be performed about 48 hours after the radiation treatment has begun. They will then study the cells in the lab with a new technique for studying gene expression called DNA array, as well as human papillomavirus (HPV) analysis, quantification of apoptosis levels, hematoxylin and eosin staining, and storage of tissue for future research.\n\nThe patterns of gene expression in the biopsies will be compared with the success of radiation treatments.\n\nSome of the material will also be stored and used in the future for other research projects.\n\nThis is an investigational study. A total of 18 patients will take part in this study. All will be enrolled at UTMDACC.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cervical cancer already scheduled to begin radiation therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed cervical cancer: clinical Stage IB -IIIB\n2. Invasive pure squamous cell carcinoma\n3. Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation\n\nExclusion Criteria:\n\n1\\. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation'}, 'identificationModule': {'nctId': 'NCT00512551', 'briefTitle': 'DNA Array Analysis of Patients With Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer', 'orgStudyIdInfo': {'id': 'IDP00-075'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cervical cancer tumor biopsy + radiation therapy', 'description': 'Cervical cancer tumor biopsy + radiation therapy.', 'interventionNames': ['Procedure: Tumor Biopsies']}], 'interventions': [{'name': 'Tumor Biopsies', 'type': 'PROCEDURE', 'description': 'Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.', 'armGroupLabels': ['Cervical cancer tumor biopsy + radiation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Anuja Jhingran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}