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Hypodontia and Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01470235
Recruitment Status : Unknown
Verified October 2013 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : November 11, 2011
Last Update Posted : November 1, 2013
Danish Cancer Society
Arvid-Nilsson Foundation
Information provided by (Responsible Party):
University of Aarhus

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

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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

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.


Patients registered in the large Danish Register of HBOC( hereditary breast and ovarian cancer) and HNPCC (hereditary nonpolyposis colorectal cancer).

Expected recruitment: 200.

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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Inclusion Criteria:

  • confirmed suspicion of ovarian cancer.

Exclusion Criteria:

  • suspicion of ovarian cancer disproved.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01470235

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Contact: Maria Cathrine C. V. Schmidt, MD, PhD-student +4578453472
Contact: Jan Blaakaer, Professor +4578450000

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Aarhus University Hospital Recruiting
Skejby, Aarhus, Denmark, 8000
Contact: Maria Cathrine C. V. Schmidt, MD, Ph.d-student    +4578453427   
Copenhagen University Hospital Recruiting
Copenhagen Ø, Copenhagen, Denmark, 2100
Contact: Maria Cathrine C.V. Schmidt, MD, Ph.d.-student    +4578453427   
Sponsors and Collaborators
University of Aarhus
Danish Cancer Society
Arvid-Nilsson Foundation
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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 at Herlev
Study Chair: Michala O. Lexner, Dentist, PhD
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Responsible Party: University of Aarhus Identifier: NCT01470235    
Other Study ID Numbers: Hypodontovariancancer2011
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Keywords provided by University of Aarhus:
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities