Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT01470235
Status:
UNKNOWN
Last Update Posted:
2013-11-01
First Post:
2011-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypodontia and Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000848', 'term': 'Anodontia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '5ml EDTA full blood for DNA analysis.\n\n1 PAX-tube for RNA analysis. Biopsi from removed tumor-tissue for DNA analysis. Both preserved in Danish Cancer Biobank for later analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-11-09', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence rates of hypodontia in women with ovarian cancer', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Genetic causes for hypodontia and ovarian cancer', 'timeFrame': 'two years'}, {'measure': 'Prevalence rates of hypodontia in patients with a known risk for epithelial cancer', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['screening', 'genetic', 'cancer'], 'conditions': ['Ovarian Cancer', 'Hypodontia', 'Breast Cancer', 'Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '18245684', 'type': 'BACKGROUND', 'citation': 'Chalothorn LA, Beeman CS, Ebersole JL, Kluemper GT, Hicks EP, Kryscio RJ, DeSimone CP, Modesitt SC. Hypodontia as a risk marker for epithelial ovarian cancer: a case-controlled study. J Am Dent Assoc. 2008 Feb;139(2):163-9. doi: 10.14219/jada.archive.2008.0132.'}, {'pmid': '10560705', 'type': 'BACKGROUND', 'citation': 'Eisinger F, Burke W, Sobol H. Management of women at high genetic risk of ovarian cancer. Lancet. 1999 Nov 6;354(9190):1648. doi: 10.1016/S0140-6736(05)77137-3. No abstract available.'}, {'pmid': '17721480', 'type': 'BACKGROUND', 'citation': 'Cobourne MT. Familial human hypodontia--is it all in the genes? Br Dent J. 2007 Aug 25;203(4):203-8. doi: 10.1038/bdj.2007.732.'}, {'pmid': '6936762', 'type': 'BACKGROUND', 'citation': 'Rolling S. Hypodontia of permanent teeth in Danish schoolchildren. Scand J Dent Res. 1980 Oct;88(5):365-9. doi: 10.1111/j.1600-0722.1980.tb01240.x.'}, {'pmid': '11370748', 'type': 'BACKGROUND', 'citation': 'Rolling S, Poulsen S. Oligodontia in Danish schoolchildren. Acta Odontol Scand. 2001 Apr;59(2):111-2. doi: 10.1080/000163501750157298.'}, {'pmid': '17998283', 'type': 'BACKGROUND', 'citation': 'Marchini S, Marabese M, Marrazzo E, Mariani P, Cattaneo D, Fossati R, Compagnoni A, Fruscio R, Lissoni AA, Broggini M. DeltaNp63 expression is associated with poor survival in ovarian cancer. Ann Oncol. 2008 Mar;19(3):501-7. doi: 10.1093/annonc/mdm519. Epub 2007 Nov 12.'}, {'pmid': '15042511', 'type': 'BACKGROUND', 'citation': 'Lammi L, Arte S, Somer M, Jarvinen H, Lahermo P, Thesleff I, Pirinen S, Nieminen P. Mutations in AXIN2 cause familial tooth agenesis and predispose to colorectal cancer. Am J Hum Genet. 2004 May;74(5):1043-50. doi: 10.1086/386293. Epub 2004 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to examine whether the risk of developing ovarian cancer is increased in Danish women with congenital missing teeth as a result of their failure to develop (hypodontia). Should this prove to be the case, these women could be offered regular clinical controls and prophylactic removal of their ovaries when menopause enters and the ovaries are no longer functional (producing hormones).\n\nIf there is a connection between congenital hypodontia and the development of different types of cancer, the investigators will perform a genetic screening in families with increased risk of cancer and hypodontia for changes in relevant genes, based on the current literature. The investigators hereby search for new genes, which in a changed form leads to an increased risk of cancer and thereby enables us to perform genetic screening in risk families.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women referred to the department of obstetrics/gynecology under the diagnosis ovarian cancer obs. pro.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed suspicion of ovarian cancer.\n\nExclusion Criteria:\n\n* suspicion of ovarian cancer disproved.'}, 'identificationModule': {'nctId': 'NCT01470235', 'briefTitle': 'Hypodontia and Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Hypodontia and Ovarian Cancer - the Connection Between Dental Agenesis and Epithelial Cancers, Especially Ovarian Cancer.', 'orgStudyIdInfo': {'id': 'Hypodontovariancancer2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ovarian Cancer', 'description': 'Women treated for ovarian cancer at the departments of obstetrics and gynecology, Aarhus University Hospital and Rigshospitalet, Copenhagen.\n\nExpected recruitment: 200'}, {'label': 'Control patients', 'description': 'Women referred to the departments of obstetrics and gynecology in Aarhus University Hospital and Rigshospitalet, Copenhagen on benign indication.\n\nExpected recruitment: 200.'}, {'label': 'HBOC/HNPCC', 'description': 'Patients registered in the large Danish Register of HBOC( hereditary breast and ovarian cancer) and HNPCC (hereditary nonpolyposis colorectal cancer).\n\nExpected recruitment: 200.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Skejby', 'state': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Maria Cathrine C. V. Schmidt, MD, Ph.d-student', 'role': 'CONTACT', 'email': 'maria.cathrine.c.v.schmidt@ki.au.dk', 'phone': '+4578453427'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.19966, 'lon': 10.17587}}, {'zip': '2100', 'city': 'Copenhagen Ø', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Maria Cathrine C.V. Schmidt, MD, Ph.d.-student', 'role': 'CONTACT', 'email': 'maria.cathrine.c.v.schmidt@ki.au.dk', 'phone': '+4578453427'}], 'facility': 'Copenhagen University Hospital'}], 'centralContacts': [{'name': 'Maria Cathrine C. V. Schmidt, MD, PhD-student', 'role': 'CONTACT', 'email': 'Maria.Cathrine.C.V.Schmidt@sun.au.dk', 'phone': '+4578453472'}, {'name': 'Jan Blaakaer, Professor', 'role': 'CONTACT', 'email': 'jab@dadlnet.dk', 'phone': '+4578450000'}], 'overallOfficials': [{'name': 'Jan Blaakaer, Professor, MD, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Maria Cathrine C. V. Schmidt, MD, Ph.d.-student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Charlotte Soegaard, MD, ph.d.', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Lone Sunde, Associate Professor, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Claus Hoegdall, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Copenhagen University Hospital at Herlev'}, {'name': 'Michala O. Lexner, Dentist, PhD', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}, {'name': 'Arvid-Nilsson Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}