Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-10 @ 12:09 PM
Study NCT ID:
NCT00503893
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2007-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009396', 'term': 'Wilms Tumor'}, {'id': 'D015783', 'term': 'Aniridia'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005124', 'term': 'Eye Abnormalities'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], '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'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Blood sample(s) for genetic testing. Also, tissue samples, and/or bodily fluids (whether healthy or cancerous) left over from surgeries or procedures performed as part of standard care. The purpose of this clinical research study is to find out why some people develop cancers and tumors, why some families have more cancers than others, and whether certain genes or regions of DNA affect a person's risk of getting cancer."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 295}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1980-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2007-07-17', 'studyFirstSubmitQcDate': '2007-07-18', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Genetic Events Involved in Development of Wilms' tumor, Genitourinary Anomalies, Hemihypertrophy and Beckwith-Wiedemann, and/or Aniridia", 'timeFrame': '32 Years (Descriptive data collected using questionnaires)', 'description': 'Characterize genetic events by a combined molecular biology/epidemiologic approach'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Wilms' Tumor", 'Genitourinary Anomalies', 'Beckwith-Wiedemann Hemihypertrophy', 'Aniridia', 'Questionnaire'], 'conditions': ["Wilms' Tumor", 'Aniridia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical research study is to collect information and blood samples to try to learn why some people develop cancers and tumors, why some families have more cancers than others, and whether certain genes or regions of DNA (the genetic material of cells) affect a person's risk of getting cancer.\n\nThis is an investigational study.\n\nUp to 1500 patients and family members will take part in this study. All will be enrolled at MD Anderson.", 'detailedDescription': 'If you choose to take part in this study, blood (about 10 teaspoons) will be drawn for genetic testing. The blood may be drawn more than 1 time, depending on how much blood is drawn at the first visit, and if you are available for more blood draws. If this is the case, your doctor will discuss any extra blood draws with you.\n\nFor small children (less than 5 years old), about 2 teaspoons will be drawn. Children who are 5 years old or older will not have more than 3 teaspoons drawn.\n\nYou will complete a questionnaire about your medical history and family medical history. The questionnaire should take about 1 hour to complete. The study staff will also review your medical records.\n\nYou will be asked to allow the study staff to collect any of your tissue (whether healthy or cancerous) that is leftover from surgeries performed as part of your standard care. This may be from any past or future surgeries or any tissue being stored at MD Anderson or elsewhere. No new surgeries or biopsies will be performed for this study.\n\nBefore your information, tissue samples, and/or bodily fluids can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your information, tissue samples, and/or bodily fluids, must first be approved by the IRB.\n\nYou may be contacted either by phone or mail 1 time a year, so that the study staff can update your medical history and information. If contacted by phone, this call should last about 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.\n\nExclusion Criteria:\n\n1\\. Patients who do not meet inclusion eligibility criteria are excluded."}, 'identificationModule': {'nctId': 'NCT00503893', 'briefTitle': "Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies", 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': "Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies", 'orgStudyIdInfo': {'id': 'P80-099'}, 'secondaryIdInfos': [{'id': 'P01CA034936-23', 'link': 'https://reporter.nih.gov/quickSearch/P01CA034936-23', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Wilm's Tumor PO1", 'description': "Familial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia.", 'interventionNames': ['Behavioral: Questionnaire', 'Other: Blood specimen']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'Questionnaire regarding medical history and family medical history that will take about 1 hour to complete.', 'armGroupLabels': ["Wilm's Tumor PO1"]}, {'name': 'Blood specimen', 'type': 'OTHER', 'description': 'Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.', 'armGroupLabels': ["Wilm's Tumor PO1"]}]}, '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': 'Louise C. Strong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}