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Hypodontia and Ovarian Cancer

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ClinicalTrials.gov 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
Information provided by (Responsible Party):

Study Description
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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Groups and 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.


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

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

Information from the National Library of Medicine

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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.

Inclusion Criteria:

  • confirmed suspicion of ovarian cancer.

Exclusion Criteria:

  • suspicion of ovarian cancer disproved.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01470235

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

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
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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01470235     History of Changes
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:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
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