Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 8:37 AM
Study NCT ID:
NCT00791635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2008-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar 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'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2008-11-13', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of surgical complications', 'timeFrame': '4 years', 'description': 'Will determine whether the number of surgical complications varies by vaginal and bladder reconstruction type.'}, {'measure': 'Short-term and long-term complications', 'timeFrame': '4 years', 'description': 'Will calculate incidence with exact 95% confidence intervals, and will calculate summary statistics. Will create the statistics using both cohorts of patients together. Will also do this separately by cohort and by vaginal reconstruction type as well as by bladder reconstruction type. A Wilcoxon rank-sum test will be used to determine whether there is a difference in number of complications by vaginal reconstruction type and by bladder reconstruction type. This will be conducted separately for each cohort. Finally, will create a Poisson regression model using both cohorts of patients with terms for cohort, vaginal reconstruction type and bladder reconstruction type as well as certain preoperative factors (albumin, electrolyte levels, body mass index) that might be predictive of number of complications.'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 5 years', 'description': 'Will summarize composite scores of the quality of life surveys by time from exenteration. This will be done separately for the retrospectively recruited patients and the prospectively recruited patients. Will also summarize information by year of surgery. To determine how quality of life changes over time, will create longitudinal models for each survey instrument given to the women. The two cohorts of women will initially be analyzed separately. A second model will be created using all patients that has terms for cohort, vaginal reconstruction type and bladder reconstruction type to determine whether these terms have an effect upon quality of life.'}, {'measure': 'Recurrence', 'timeFrame': 'Up to 5 years', 'description': 'Will calculate median time to recurrence in patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of recurrence such as histology, size of tumor, and distance of closest margin.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 5 years', 'description': 'Will calculate overall survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.'}, {'measure': 'Disease-free survival', 'timeFrame': 'Up to 5 years', 'description': 'Will calculate disease-free survival of patients who undergo pelvic exenteration. Will use log-rank tests and construct proportional hazards models to evaluate pathologic predictors of survival such as histology, size of tumor, and distance of closest margin.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Carcinoma', 'Endometrial Carcinoma', 'Malignant Female Reproductive System Neoplasm', 'Vaginal Carcinoma', 'Vulvar Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The study investigates whether certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from surgery to remove the lower colon, rectum, and bladder, and create openings through which urine and stool are passed out of the body (pelvic exenteration). Comparing the types of surgery completed and procedures used may help researchers to determine which are most effective and safe in patients with a history of gynecologic cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the types of complications experienced by women who undergo pelvic exenteration at University of Texas (UT) MD Anderson Cancer Center.\n\nII. To determine whether the number of complications experienced by women who undergo pelvic exenteration at UT MD Anderson Cancer Center differ by vaginal and bladder reconstruction types.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate pathologic predictors of recurrence including histology, size of tumor, and distance of closest margin.\n\nII. To longitudinally assess quality of life, sexual functioning, and symptoms in women who have undergone pelvic exenteration for gynecologic malignancies.\n\nIII. To assess the impact of certain preoperative factors (albumin, electrolyte levels, body mass index) on the occurrence of post-operative complications.\n\nIV. To determine if preoperative positron emission tomography (PET)/computed tomography (CT) correlates with pathologic findings at the time of surgery.\n\nV. To calculate time to recurrence, overall survival, and disease-free survival of patients who undergo pelvic exenteration and correlate to key demographic, clinical, and pathologic factors.\n\nOUTLINE:\n\nRETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of quality of life (QOL) questionnaires.\n\nPROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.\n\nPatients who undergo surgery are followed up every 3 months for the first 2 years, and then every 6 months for 3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with a history of gynecologic malignancy who have undergone or are being offered a pelvic exenteration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology\n* Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy\n* Patients must be suitable candidates for surgery (in case of prospective collection)\n* Patients who have signed an approved informed consent\n* Patients with a prior malignancy allowed if \\> 3 years previous with no current evidence of disease\n* Women must be able to read and write in either Spanish or English\n\nExclusion Criteria:\n\n* Patients with contraindications to surgery\n* Patients unwilling or unable to complete self-administered questionnaires\n* Patients who do not read or speak English or Spanish'}, 'identificationModule': {'nctId': 'NCT00791635', 'briefTitle': 'Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy', 'orgStudyIdInfo': {'id': '2008-0095'}, 'secondaryIdInfos': [{'id': 'NCI-2020-07746', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2008-0095', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (questionnaires)', 'description': 'RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of QOL questionnaires.\n\nPROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Observational (questionnaires)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (questionnaires)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Pamela T Soliman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}