Hypodontia and Ovarian Cancer

NCT01470235 | Unknown DMC

• 1 other identifier: Hypodontovariancancer2011
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer; Hypodontia; Breast Cancer; Colon Cancer

Keywords

screening; genetic; cancer

Outcome Measures

Primary Outcomes (1)

• Prevalence rates of hypodontia in women with ovarian cancer

  one year

Secondary Outcomes (2)

• Genetic causes for hypodontia and ovarian cancer

  two years

• Prevalence rates of hypodontia in patients with a known risk for epithelial cancer

  one year

Study Arms (3)

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All women referred to the department of obstetrics/gynecology under the diagnosis ovarian cancer obs. pro.

You may qualify if:

• confirmed suspicion of ovarian cancer.

You may not qualify if:

• suspicion of ovarian cancer disproved.

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Cancer Society: collaborator
• Arvid-Nilsson Foundation: collaborator

Study Sites (2)

Aarhus University Hospital

Skejby, Aarhus, 8000, Denmark

RECRUITING

Copenhagen University Hospital

Copenhagen Ø, Copenhagen, 2100, Denmark

RECRUITING

Related Publications (7)

• 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.

  PMID: 18245684 BACKGROUND

• 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.

  PMID: 10560705 BACKGROUND

• 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.

  PMID: 17721480 BACKGROUND

• 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.

  PMID: 6936762 BACKGROUND

• Rolling S, Poulsen S. Oligodontia in Danish schoolchildren. Acta Odontol Scand. 2001 Apr;59(2):111-2. doi: 10.1080/000163501750157298.

  PMID: 11370748 BACKGROUND

• 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.

  PMID: 17998283 BACKGROUND

• 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.

  PMID: 15042511 BACKGROUND

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.

MeSH Terms

Conditions

Ovarian Neoplasms; Anodontia; Breast Neoplasms; Colonic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Jan Blaakaer, Professor, MD, DMSc

  Aarhus University Hospital

  STUDY DIRECTOR

• Maria Cathrine C. V. Schmidt, MD, Ph.d.-student

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Maria Cathrine C. V. Schmidt, MD, PhD-student

CONTACT

+4578453472; Maria.Cathrine.C.V.Schmidt@sun.au.dk

Jan Blaakaer, Professor

CONTACT

+4578450000; jab@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: August 1, 2015
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DK (2)