Hypodontia and Ovarian Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2013 by University of Aarhus.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Danish Cancer Society

Arvid-Nilsson Foundation

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01470235

First received: November 9, 2011

Last updated: October 31, 2013

Last verified: October 2013

History of Changes

Purpose

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
Ovarian Cancer Hypodontia Breast Cancer Colon Cancer


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Hypodontia and Ovarian Cancer - the Connection Between Dental Agenesis and Epithelial Cancers, Especially Ovarian Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer ovarian cancer

MedlinePlus related topics: Cancer Ovarian Cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Anodontia

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Prevalence rates of hypodontia in women with ovarian cancer [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Genetic causes for hypodontia and ovarian cancer [ Time Frame: two years ] [ Designated as safety issue: No ]
Prevalence rates of hypodontia in patients with a known risk for epithelial cancer [ Time Frame: one year ] [ Designated as safety issue: No ]

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.


Estimated Enrollment:	200
Study Start Date:	September 2011
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470235

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

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
Study First Received:	November 9, 2011
Last Updated:	October 31, 2013
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:


screening genetic cancer

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 26, 2016

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