Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 11:47 PM
Study NCT ID:
NCT00935233
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2009-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}], 'ancestors': [{'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '2009-07-07', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of blood and/or tumor tissue'}, {'measure': 'Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS)'}, {'measure': 'Effect of these variants on tumor risk'}, {'measure': 'Benefit of testing for these variants'}], 'secondaryOutcomes': [{'measure': 'Analysis of acquired genetic changes within DCIS'}]}, 'conditionsModule': {'keywords': ['ductal breast carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying genes in samples of blood and/or tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.\n\nPURPOSE: This research study is looking at blood and/or tumor tissue samples from patients with ductal carcinoma in situ and blood samples from healthy volunteers.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To collect blood and/or tumor tissue of patients with ductal breast carcinoma in situ (DCIS) and their age- and ethnicity-matched controls to identify the inherited variation that predisposes women to develop DCIS.\n* To determine the frequency of these variants.\n* To determine the effect of these variants on tumor risk.\n* To determine the benefit of testing for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.\n\nSecondary\n\n* To analyze the acquired genetic changes within DCIS to identify which cases are more likely to develop invasive disease.\n\nOUTLINE: This is a multicenter study.\n\nAll participants complete a questionnaire to collect their family history, a brief medical history, and epidemiological data.\n\nPatients undergo collection of blood and/or tumor tissue samples; DNA is extracted for genotyping, comparison of allele and genotype frequencies (polymorphisms), genetic profiling, DNA analysis, and protein analysis. Histopathology reports are also collected. Healthy volunteers undergo collection of blood samples.\n\nPROJECTED ACCRUAL: A minimum of 3,000 patients and 3,000 controls will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Prior or current diagnosis of pure ductal carcinoma in situ (DCIS)\n\n * Age ≤ 60 years at the time of diagnosis\n * DCIS with contralateral synchronous or asynchronous invasive breast cancer is permitted\n * DCIS associated with microinvasion (foci \\< 1 mm) is permitted\n* Healthy age- and ethnicity-matched controls\n\n * No history of DCIS\n * No relative (up to second degree) diagnosed with DCIS\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00935233', 'briefTitle': 'Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE', 'orgStudyIdInfo': {'id': 'CRUK-ICICLE'}, 'secondaryIdInfos': [{'id': 'CDR0000629681', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20895'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC'}, {'name': 'polymorphism analysis', 'type': 'GENETIC'}, {'name': 'protein analysis', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'survey administration', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX31 4JB', 'city': 'Barnstaple', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1271-322-577'}], 'facility': 'North Devon District Hospital', 'geoPoint': {'lat': 51.08022, 'lon': -4.05808}}, {'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1702-435-555'}], 'facility': 'Basildon University Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michael Williams, MD', 'role': 'CONTACT', 'email': 'michael.williams@addenbrookes.nhs.uk', 'phone': '44-122-321-7020'}], 'facility': 'Cumberland Infirmary', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CO4 5HG', 'city': 'Colchester', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1206-744-893'}], 'facility': 'Colchester General Hospital', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'zip': 'DA1 5PL', 'city': 'Dartford Kent', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1322-227-242'}], 'facility': 'Dartford & Gravesham NHS Trust, Joyce Green Hospital'}, {'zip': 'DT1 2JY', 'city': 'Dorchester', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1305-251-150'}], 'facility': 'Dorset County Hospital', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-20-8864-3232'}], 'facility': 'Northwick Park Hospital', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'TW7 6AF', 'city': 'Isleworth', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-20-8321-6781'}], 'facility': 'West Middlesex University Hospital', 'geoPoint': {'lat': 51.47518, 'lon': -0.34246}}, {'zip': 'EC1M 6BQ', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rebecca Roylance, MD', 'role': 'CONTACT', 'phone': '44-20-7014-0460'}], 'facility': 'Barts and the London School of Medicine', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'N18 1QX', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-20-7830-2184'}], 'facility': 'Helen Rollason Cancer Care Centre at North Middlesex Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RT', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Elinor Sawyer, MD', 'role': 'CONTACT', 'phone': '44-171-737-3642'}], 'facility': "Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-20-3299-9000'}], 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Charles P. Lowdell, MD, BSc, MBBS, FRCP, FRCR', 'role': 'CONTACT', 'email': 'charles.lowdell@imperial.nhs.uk', 'phone': '44-20-8846-1742'}], 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1923-844-805'}], 'facility': 'Mount Vernon Cancer Centre at Mount Vernon Hospital', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'BR6 8ND', 'city': 'Orpington, Kent', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Elinor Sawyer, MD', 'role': 'CONTACT', 'phone': '44-20-7188-3751'}], 'facility': 'Princess Royal University Hospital'}, {'zip': 'SS0 0RY', 'city': 'Westcliff-on-Sea', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Anne Robinson, MD', 'role': 'CONTACT', 'phone': '44-1702-221-226'}], 'facility': 'Southend University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}, {'zip': 'DG1 4AP', 'city': 'Dumfries', 'state': 'Scotland', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1387-246-246'}], 'facility': 'Dumfries & Galloway Royal Infirmary', 'geoPoint': {'lat': 55.06959, 'lon': -3.61139}}, {'zip': 'SY23 1ER', 'city': 'Aberystwyth', 'state': 'Wales', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1970-635-390'}], 'facility': 'Bronglais District General Hospital', 'geoPoint': {'lat': 52.41548, 'lon': -4.08292}}], 'overallOfficials': [{'name': 'Rebecca Roylance, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts and the London School of Medicine and Dentistry'}, {'name': 'Elinor Sawyer, MD', 'affiliation': 'Cancer Research UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}}}}