Clinical trial NCT01470235: Hypodontia and Ovarian Cancer
Official title: Hypodontia and Ovarian Cancer - the Connection Between Dental Agenesis and Epithelial Cancers, Especially Ovarian Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Hypodontia
Breast Cancer
Colon Cancer
Keywords: screening
genetic
cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Arvid-Nilsson Foundation
First posted: 2011-11-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women referred to the department of obstetrics/gynecology under the diagnosis ovarian cancer obs. pro.

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.


Eligibility criteria: Inclusion Criteria:

* confirmed suspicion of ovarian cancer.

Exclusion Criteria:

* suspicion of ovarian cancer disproved.

Primary outcomes:
measure: Prevalence rates of hypodontia in women with ovarian cancer
timeFrame: one year
Secondary outcomes:
measure: Genetic causes for hypodontia and ovarian cancer
timeFrame: two years
measure: Prevalence rates of hypodontia in patients with a known risk for epithelial cancer
timeFrame: one year
Other outcomes:
Locations:
city: Skejby
country: Denmark
facility: Aarhus University Hospital
state: Aarhus
city: Copenhagen Ø
country: Denmark
facility: Copenhagen University Hospital
state: Copenhagen
Study officials:
affiliation: Aarhus University Hospital
name: Jan Blaakaer, Professor, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital
name: Maria Cathrine C. V. Schmidt, MD, Ph.d.-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Charlotte Soegaard, MD, ph.d.
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Lone Sunde, Associate Professor, PhD
role: STUDY_CHAIR
affiliation: Copenhagen University Hospital at Herlev
name: Claus Hoegdall, Professor
role: STUDY_CHAIR
name: Michala O. Lexner, Dentist, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Rolling S, Poulsen S. Oligodontia in Danish schoolchildren. Acta Odontol Scand. 2001 Apr;59(2):111-2. doi: 10.1080/000163501750157298.
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. doi: 10.1093/annonc/mdm519. Epub 2007 Nov 12.
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. doi: 10.1086/386293. Epub 2004 Mar 23.