- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470235
Hypodontia and Ovarian Cancer
Hypodontia and Ovarian Cancer - the Connection Between Dental Agenesis and Epithelial Cancers, Especially Ovarian Cancer.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Maria Cathrine C. V. Schmidt, MD, PhD-student
- Phone Number: +4578453472
- Email: Maria.Cathrine.C.V.Schmidt@sun.au.dk
Study Contact Backup
- Name: Jan Blaakaer, Professor
- Phone Number: +4578450000
- Email: jab@dadlnet.dk
Study Locations
-
-
Aarhus
-
Skejby, Aarhus, Denmark, 8000
- Recruiting
- Aarhus University Hospital
-
Contact:
- Maria Cathrine C. V. Schmidt, MD, Ph.d-student
- Phone Number: +4578453427
- Email: maria.cathrine.c.v.schmidt@ki.au.dk
-
-
Copenhagen
-
Copenhagen Ø, Copenhagen, Denmark, 2100
- Recruiting
- Copenhagen University Hospital
-
Contact:
- Maria Cathrine C.V. Schmidt, MD, Ph.d.-student
- Phone Number: +4578453427
- Email: maria.cathrine.c.v.schmidt@ki.au.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- confirmed suspicion of ovarian cancer.
Exclusion Criteria:
- suspicion of ovarian cancer disproved.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence rates of hypodontia in women with ovarian cancer
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Genetic causes for hypodontia and ovarian cancer
Time Frame: two years
|
two years
|
Prevalence rates of hypodontia in patients with a known risk for epithelial cancer
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
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 at Herlev
- Study Chair: Michala O. Lexner, Dentist, PhD
Publications and helpful links
General 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. doi: 10.14219/jada.archive.2008.0132.
- Eisinger F, Burke W, Sobol H. Management of women at high genetic risk of ovarian cancer. Lancet. 1999 Nov 6;354(9190):1648. doi: 10.1016/S0140-6736(05)77137-3. No abstract available.
- Cobourne MT. Familial human hypodontia--is it all in the genes? Br Dent J. 2007 Aug 25;203(4):203-8. doi: 10.1038/bdj.2007.732.
- Rolling S. Hypodontia of permanent teeth in Danish schoolchildren. Scand J Dent Res. 1980 Oct;88(5):365-9. doi: 10.1111/j.1600-0722.1980.tb01240.x.
- Rolling S, Poulsen S. Oligodontia in Danish schoolchildren. Acta Odontol Scand. 2001 Apr;59(2):111-2. doi: 10.1080/000163501750157298.
- 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. doi: 10.1093/annonc/mdm519. 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. doi: 10.1086/386293. Epub 2004 Mar 23.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Congenital Abnormalities
- Endocrine Gland Neoplasms
- Stomatognathic Diseases
- Tooth Diseases
- Stomatognathic System Abnormalities
- Tooth Abnormalities
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Anodontia
Other Study ID Numbers
- Hypodontovariancancer2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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