Hypodontia and Ovarian Cancer

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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).

If 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.

Condition or disease
Ovarian Cancer; Hypodontia; Breast Cancer; Colon Cancer

Study Design

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Study Type :	Observational
Estimated Enrollment :	200 participants
Observational Model:	Case Control
Time Perspective:	Retrospective
Official Title:	Hypodontia and Ovarian Cancer - the Connection Between Dental Agenesis and Epithelial Cancers, Especially Ovarian Cancer.
Study Start Date :	September 2011
Estimated Primary Completion Date :	September 2014
Estimated Study Completion Date :	August 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Ovarian Cancer; Women treated for ovarian cancer at the departments of obstetrics and gynecology, Aarhus University Hospital and Rigshospitalet, Copenhagen. Expected recruitment: 200
Control patients; Women referred to the departments of obstetrics and gynecology in Aarhus University Hospital and Rigshospitalet, Copenhagen on benign indication. Expected recruitment: 200.
HBOC/HNPCC; Patients registered in the large Danish Register of HBOC( hereditary breast and ovarian cancer) and HNPCC (hereditary nonpolyposis colorectal cancer). Expected recruitment: 200.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Prevalence rates of hypodontia in women with ovarian cancer [ Time Frame: one year ]

Secondary Outcome Measures :

1. Genetic causes for hypodontia and ovarian cancer [ Time Frame: two years ]
2. Prevalence rates of hypodontia in patients with a known risk for epithelial cancer [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA

5ml EDTA full blood for DNA analysis.

1 PAX-tube for RNA analysis. Biopsi from removed tumor-tissue for DNA analysis. Both preserved in Danish Cancer Biobank for later analysis.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

All women referred to the department of obstetrics/gynecology under the diagnosis ovarian cancer obs. pro.

Criteria

Inclusion Criteria:

• confirmed suspicion of ovarian cancer.

Exclusion Criteria:

• suspicion of ovarian cancer disproved.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Maria Cathrine C. V. Schmidt, MD, PhD-student	+4578453472	Maria.Cathrine.C.V.Schmidt@sun.au.dk
Contact: Jan Blaakaer, Professor	+4578450000	jab@dadlnet.dk

Locations

Denmark
Aarhus University Hospital	Recruiting
Skejby, Aarhus, Denmark, 8000
Contact: Maria Cathrine C. V. Schmidt, MD, Ph.d-student +4578453427 maria.cathrine.c.v.schmidt@ki.au.dk
Copenhagen University Hospital	Recruiting
Copenhagen Ø, Copenhagen, Denmark, 2100
Contact: Maria Cathrine C.V. Schmidt, MD, Ph.d.-student +4578453427 maria.cathrine.c.v.schmidt@ki.au.dk

Sponsors and Collaborators

University of Aarhus

Danish Cancer Society

Arvid-Nilsson Foundation

Investigators

Study Director:	Jan Blaakaer, Professor, MD, DMSc	Aarhus University Hospital
Principal Investigator:	Maria Cathrine C. V. Schmidt, MD, Ph.d.-student	Aarhus University Hospital
Study Chair:	Charlotte Soegaard, MD, ph.d.	Aarhus University Hospital
Study Chair:	Lone Sunde, Associate Professor, PhD	Aarhus University Hospital
Study Chair:	Claus Hoegdall, Professor	Copenhagen University Hospital
Study Chair:	Michala O. Lexner, Dentist, PhD

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Eisinger F, Burke W, Sobol H. Management of women at high genetic risk of ovarian cancer. Lancet. 1999 Nov 6;354(9190):1648.

Cobourne MT. Familial human hypodontia--is it all in the genes? Br Dent J. 2007 Aug 25;203(4):203-8. Review.

Rølling S. Hypodontia of permanent teeth in Danish schoolchildren. Scand J Dent Res. 1980 Oct;88(5):365-9.

Rølling S, Poulsen S. Oligodontia in Danish schoolchildren. Acta Odontol Scand. 2001 Apr;59(2):111-2.

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. Epub 2007 Nov 12.

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. Epub 2004 Mar 23.

Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01470235 History of Changes
Other Study ID Numbers:	Hypodontovariancancer2011
First Posted:	November 11, 2011
Last Update Posted:	November 1, 2013
Last Verified:	October 2013

Keywords provided by University of Aarhus:

screening; genetic; cancer

Additional relevant MeSH terms:

Ovarian Neoplasms; Anodontia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female	Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities