Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT00604994
Status:
COMPLETED
Last Update Posted:
2013-08-20
First Post:
2008-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'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': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 761}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-18', 'studyFirstSubmitDate': '2008-01-13', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of onset of lymphoedema after gynaecological cancer treatment.', 'timeFrame': '2 years'}, {'measure': 'Incidence of lymphoedema after gynaecological cancer treatment.', 'timeFrame': '2 years'}, {'measure': 'Point prevalence of lymphoedema after gynaecological cancer treatment.', 'timeFrame': '2 years'}, {'measure': 'Severity of lymphoedema after gynaecological cancer treatment.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.', 'timeFrame': '2 years'}, {'measure': 'Impact of risk factors on development of lymphoedema.', 'timeFrame': '2 years'}, {'measure': 'Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymphoedema', 'Gynaecology', 'Oncology', 'Malignant', 'Benign', 'Incidence'], 'conditions': ['Female Genital Diseases', 'Ovarian Cancer', 'Cervical Cancer', 'Endometrial Cancer', 'Vulval Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gyncan.org/', 'label': 'QCGC Research'}]}, 'descriptionModule': {'briefSummary': 'This project will conduct a prospective, longitudinal, observational cohort study to assess the onset and incidence of lymphoedema, as well as investigate factors associated with its development among women newly diagnosed with gynaecological cancers in 2008 to 2011.', 'detailedDescription': "Pathological swelling of the lower limbs (lymphoedema) is widely accepted to be a common consequence of treatment for gynaecological cancer. It is both a serious and debilitating complication, associated with significant morbidity, which impacts physically and emotionally on otherwise healthy women. Lymphoedema can also affect patients' ability to earn an income, especially if their work requires prolonged periods of standing or walking.\n\nThe causes of lymphoedema are largely unknown with clinical data scarce regarding its onset time and incidence after gynaecological cancer treatment.\n\nThe following hypotheses will be tested to address the aims of the project:\n\n1. At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.\n2. Patient's age, as well as their body mass index (BMI), area of residence, degree of physical exercise, type of disease (uterine, cervical, ovarian, vulval/vaginal cancer; benign disease), mode of treatment (extent of lymph node dissection, radiotherapy, chemoradiation) and delay in wound healing are independent risk factors for lower-limb lymphoedema.\n3. Patients who develop lymphoedema after gynaecological cancer treatment, will experience increased pain, lower quality of life (including worse body-image), and decreased sexual \\& financial well-being, compared to those who do not develop lymphoedema.\n4. There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with gynaecological conditons requiring treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for surgery of benign or malignant gynaecological diseases as determined jointly by the surgeon and the patient.\n* Non-pregnant female patients.\n* Over 18 years of age at time of surgery.\n* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.\n* Patients who are capable of, and have given, informed consent to their participation in the study.\n\nExclusion Criteria:\n\n* Patients with a pacemaker.\n* Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.'}, 'identificationModule': {'nctId': 'NCT00604994', 'acronym': 'LEGS', 'briefTitle': 'Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Queensland Centre for Gynaecological Cancer'}, 'officialTitle': 'Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer', 'orgStudyIdInfo': {'id': 'LEGS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Malignant', 'description': 'Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina'}, {'label': 'Benign', 'description': 'Patients without malignant gynaecological cancers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Wesley Hospital', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '4120', 'city': 'Greenslopes', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Greenslopes Private Hospital', 'geoPoint': {'lat': -27.50815, 'lon': 153.04951}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Mater Health Services', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Women's Hospital", 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}], 'overallOfficials': [{'name': 'Andreas Obermair, MD FRANZCOG CGO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queensland Centre for Gynaecological Cancer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queensland Centre for Gynaecological Cancer', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The University of Queensland', 'class': 'OTHER'}, {'name': "Royal Brisbane and Women's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Mater', 'class': 'OTHER'}, {'name': 'Mater Private Hospital', 'class': 'OTHER'}, {'name': 'Queensland Institute of Medical Research', 'class': 'OTHER'}, {'name': 'Queensland University of Technology', 'class': 'OTHER'}, {'name': 'Australia New Zealand Gynaecological Oncology Group', 'class': 'OTHER'}, {'name': 'Cancer Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}