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Hypodontia and Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Aarhus
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:

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
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:

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
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Ovarian Diseases
 Urogenital Neoplasms
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders

ClinicalTrials.gov processed this record on March 03, 2015