Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-06 @ 4:41 PM
Study NCT ID:
NCT00495950
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2007-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Measurement of Post-Treatment Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2007-07-02', 'studyFirstSubmitQcDate': '2007-07-02', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of incidences of lymphedema following surgical treatment of stage I, II, and III cutaneous malignant melanoma', 'timeFrame': '30 Month Period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Lymphedema', 'Limb Swelling', 'Questionnaire', 'Quality of Life', 'Physical Function', 'Survey'], 'conditions': ['Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to measure the amount of limb swelling (lymphedema) that sometimes occurs after melanoma treatment, and to find out how people feel and react to the diagnosis and treatment of melanoma.', 'detailedDescription': 'If you choose to take part in this study, you will have measurements taken of your arms or legs using a Perometer and a bioimpedance machine. The Perometer is a machine that painlessly measures the fluid in your limb using two-directional infrared lights. These lights are located in the frame of the machine that encircles the arm or leg during the measurement. The bioimpedance is a machine that measures the fluid in your arm or leg by passing a very small current through the body similar to an electrocardiogram (EKG). These very small currents are located in electrodes that are placed on the hands and feet during the measurement. Both machines are able to pick up changes in limb size.\n\nYou will also be asked to complete a set of questionnaires relating to any symptoms that you may experience in your limbs and/or trunk (chest, stomach, and hip areas) during and following your standard cancer treatment.\n\nAdditional questionnaires, along with your limb measurements, will be done at your regularly-scheduled follow-up clinic visits, 3-6 months, 9-12 months, 15-18 months, 21-24 months and 27- 30 months. You will complete the additional questionnaires using a laptop computer or a hardcopy. The measurements and questionnaires will take 45-60 minutes to complete each time.\n\nSome of the data from this study may be sent to the University of Missouri for analysis. The data that is sent will not have any personal identifiers. Researchers at University of Missouri will not be able to link the data to the protected health information or personal identity of any individual participant.\n\nThis is an investigational study. Up to 350 patients will take part in this study. All patients will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III) will be recruited for participation as they present for their initial clinical evaluation to the University of Texas M.D. Anderson Melanoma and Skin Center.\n2. Prior to surgical treatment\n3. Patients who can knowledgeably and voluntarily provide an informed consent to participate. The informed consent will be signed and dated.\n4. Fluent in English.\n5. At least 18 years of age.\n\nExclusion Criteria:\n\n1. Patients with a prior history of lymphedema or melanoma prior to treatment.\n2. Patients who are unable to consent due to other medical illnesses or disorientation to person, place or time.\n3. Patients with known distant metastatic disease (Stage IV).\n4. Patients with implanted device (pace maker), orthopedic implants, and metal frames.\n5. Presence of concurrent malignancy that requires active treatment, such as chemotherapy or biotherapy, prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT00495950', 'briefTitle': 'Prospective Measurement of Post-Treatment Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma', 'orgStudyIdInfo': {'id': '2004-0787'}, 'secondaryIdInfos': [{'id': '5K12CA088084', 'link': 'https://reporter.nih.gov/quickSearch/5K12CA088084', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaire', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'Questionnaires relating to symptoms experienced during and following standard cancer treatment.', 'armGroupLabels': ['Questionnaire']}]}, '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': 'Janice N. Cormier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Oncology Research Development Program', 'class': 'UNKNOWN'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}