Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-29 @ 8:14 AM
Study NCT ID:
NCT04655066
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint', 'timeFrame': '12 months', 'description': 'The primary endpoint and basis for the sample size calculation is the incidence of clinically relevant deteriorations in the total score of pelvic floor function.\n\nBladder function, bowel function, sedimentation problems and sexual function, QoL are recorded using scores using the validated German pelvic floor questionnaire'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint', 'timeFrame': '12 months', 'description': 'Type of tumor (breast cancer, ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer), TNM stage, body weight, height, age, type of tumor therapy, number of previous therapies (chemoline), parity, mode of delivery, nicotine abuse, medication, previous surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Floor Disorders']}, 'descriptionModule': {'briefSummary': 'The multimodal therapy of gynecological malignancies and breast cancer often leads to an impairment of the pelvic floor function. This has a major impact on the quality of life of cancer patients. The aim of the study is to record and analyze the potential subjective impairment of the bladder, bowel and sexual function under systemic tumor therapy as well as possible influencing factors by means of validated disease-specific questionnaires. to find possible starting points for the prevention and treatment of the symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with gynecological tumors and breast cancer under systemic tumor therapy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breastcancer under tumor therapy\n* Gynecological carcinoma under tumor therapy\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04655066', 'briefTitle': 'Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'St. Josefs-Hospital Wiesbaden GmbH'}, 'officialTitle': 'PANTHERA-Studie "Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy"', 'orgStudyIdInfo': {'id': 'PANTHERA'}}, 'contactsLocationsModule': {'locations': [{'zip': '65189', 'city': 'Wiesbaden', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'St. Josefs-Hospital Wiesbaden GmbH', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'centralContacts': [{'name': 'Boris Gabriel, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'bgabriel@joho.de', 'phone': '+496111771500'}, {'name': 'Bettina Blau-Schneider, Dr. med.', 'role': 'CONTACT', 'email': 'bblauschneider@joho.de', 'phone': '+496111770'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Josefs-Hospital Wiesbaden GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}