Hypodontia and Ovarian Cancer

NCT ID: NCT01470235

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer Hypodontia Breast Cancer Colon Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

screening genetic cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ovarian Cancer

Women treated for ovarian cancer at the departments of obstetrics and gynecology, Aarhus University Hospital and Rigshospitalet, Copenhagen.

Expected recruitment: 200

No interventions assigned to this group

Control patients

Women referred to the departments of obstetrics and gynecology in Aarhus University Hospital and Rigshospitalet, Copenhagen on benign indication.

Expected recruitment: 200.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* confirmed suspicion of ovarian cancer.

Exclusion Criteria

* suspicion of ovarian cancer disproved.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Cancer Society

OTHER

Sponsor Role collaborator

Arvid-Nilsson Foundation

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Blaakaer, Professor, MD, DMSc

Role: STUDY_DIRECTOR

Aarhus University Hospital

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

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Charlotte Soegaard, MD, ph.d.

Role: STUDY_CHAIR

Aarhus University Hospital

Lone Sunde, Associate Professor, PhD

Role: STUDY_CHAIR

Aarhus University Hospital

Claus Hoegdall, Professor

Role: STUDY_CHAIR

Copenhagen University Hospital at Herlev

Michala O. Lexner, Dentist, PhD

Role: STUDY_CHAIR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aarhus University Hospital

Skejby, Aarhus, Denmark

Site Status RECRUITING

Copenhagen University Hospital

Copenhagen Ø, Copenhagen, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

Phone: +4578453472

Email: [email protected]

Jan Blaakaer, Professor

Role: CONTACT

Phone: +4578450000

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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

Role: primary

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

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18245684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10560705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17721480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6936762 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11370748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17998283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15042511 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hypodontovariancancer2011

Identifier Type: -

Identifier Source: org_study_id