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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01470235
Other study ID # Hypodontovariancancer2011
Secondary ID
Status Recruiting
Phase N/A
First received November 9, 2011
Last updated October 31, 2013
Start date September 2011
Est. completion date August 2015

Study information

Verified date October 2013
Source University of Aarhus
Contact Maria Cathrine C. V. Schmidt, MD, PhD-student
Phone +4578453472
Email Maria.Cathrine.C.V.Schmidt@sun.au.dk
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 2015
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- confirmed suspicion of ovarian cancer.

Exclusion Criteria:

- suspicion of ovarian cancer disproved.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Locations

Country Name City State
Denmark Copenhagen University Hospital Copenhagen Ø Copenhagen
Denmark Aarhus University Hospital Skejby Aarhus

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Arvid-Nilsson Foundation, Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View Citation

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

Eisinger F, Burke W, Sobol H. Management of women at high genetic risk of ovarian cancer. Lancet. 1999 Nov 6;354(9190):1648. — View 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. Epub 2004 Mar 23. — View 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. Epub 2007 Nov 12. — View Citation

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

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

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence rates of hypodontia in women with ovarian cancer one year No
Secondary Genetic causes for hypodontia and ovarian cancer two years No
Secondary Prevalence rates of hypodontia in patients with a known risk for epithelial cancer one year No
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