Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-10 @ 12:30 AM
Study NCT ID:
NCT00536718
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2007-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetics of Women With Lobular Carcinoma in Situ of the Breast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018275', 'term': 'Carcinoma, Lobular'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}], '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': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D025202', 'term': 'Molecular Diagnostic Techniques'}, {'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '2007-09-27', 'studyFirstSubmitQcDate': '2007-09-27', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inherited variation predisposing development of lobular carcinoma in situ (LCIS) of the breast in women'}, {'measure': 'Frequency and effect of variants on tumor risk'}, {'measure': 'Clinical setting variant test value in identifying, counseling and screening those women at higher risk'}], 'secondaryOutcomes': [{'measure': 'LCIS genetic changes which may progress to invasive cancer'}]}, 'conditionsModule': {'keywords': ['invasive lobular breast carcinoma with predominant in situ component', 'invasive lobular breast carcinoma', 'lobular breast carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Gathering information about genetic changes in patients with lobular carcinoma in situ of the breast may help doctors learn more about the disease and find better methods of treatment.\n\nPURPOSE: This clinical trial is studying the genetics of women with lobular carcinoma in situ of the breast.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Identify inherited variation that predisposes women to develop lobular carcinoma in situ (LCIS) of the breast.\n* Identify the frequency of these variants and determine the effect they have on tumor risk.\n* Determine how worthwhile it would be to test for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.\n\nSecondary\n\n* Analysis of genetic changes within LCIS with the aim of identifying cases of LCIS which may progress to invasive cancer.\n\nOUTLINE: Patients and control participants undergo blood collection. DNA is extracted from blood samples and used to genotype at selected polymorphisms, compare allele frequencies (used to associate alleles with disease) using a genome-wide single nucleotide polymorphism (SNP) screen. Archival tumor samples (if available) from patients are used for DNA-, RNA-, or protein-based analyses.\n\nAll participants complete a questionnaire about family history, a brief medical history, and provide epidemiological data to a genetic counselor. Participants identified to be at risk for known hereditary predisposition to cancer will be referred to a clinical genetics service. Individual results of this study are not disclosed to participants.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK.\n\nPROJECTED ACCRUAL: A total of 2,000 participants (1,000 patients and 1,000 matched controls) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * Current or prior diagnosis of lobular carcinoma in situ (LCIS) of the breast, including any of the following cases:\n\n * Pure LCIS\n * LCIS with subsequent development of invasive breast cancer of any morphological subtype\n * LCIS presenting as an incidental finding together with invasive breast cancer of any morphological subtype\n * Control participant matched for age and ethnicity to each LCIS patient\n\n * Not affected by LCIS\n * No history of ductal carcinoma in situ of the breast\n * No breast cancer\n * No relative (up to 2nd degree) who has been affected by breast cancer\n * Male or female\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00536718', 'briefTitle': 'Genetics of Women With Lobular Carcinoma in Situ of the Breast', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope', 'orgStudyIdInfo': {'id': 'NCRN-CRUK-GLACIER'}, 'secondaryIdInfos': [{'id': 'CDR0000566209', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20760'}, {'id': 'MREC 06/Q1702/64'}, {'id': 'CRUK-GLACIER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'molecular diagnostic method', 'type': 'GENETIC'}, {'name': 'polymorphism analysis', 'type': 'GENETIC'}, {'name': 'protein expression analysis', 'type': 'GENETIC'}, {'name': 'medical chart review', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1268-533-911'}], 'facility': 'Basildon University Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'DE1 2QY', 'city': 'Derby', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1332-347-141'}], 'facility': 'Derbyshire Royal Infirmary', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-113-243-2799'}], 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SE1 9RT', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-20-7188-7188'}], 'facility': "Guy's Hospital", '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', 'email': 'info@kingsch.nhs.uk', 'phone': '44-20-3299-9000'}], 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC2A 3PX', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Elinor Sawyer, MD', 'role': 'CONTACT', 'phone': '44-20-7269-2884'}], 'facility': 'London Research Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SS0 0RY', 'city': 'Westcliff-on-Sea', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1702-435-555'}], 'facility': 'Southend University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}, {'zip': 'SY23 1ER', 'city': 'Aberystwyth', 'state': 'Wales', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-1970-623-131'}], 'facility': 'Bronglais District General Hospital', 'geoPoint': {'lat': 52.41548, 'lon': -4.08292}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-20-7377-7000'}], 'facility': "Saint Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Elinor Sawyer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'London Research Institute'}, {'name': 'Rebecca Roylance, MD', 'affiliation': 'Barts and the London School of Medicine and Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Research Network', 'class': 'NETWORK'}}}}