Hypodontia and Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT01470235 |
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Recruitment Status : Unknown
Verified October 2013 by University of Aarhus.
Recruitment status was: Recruiting
First Posted : November 11, 2011
Last Update Posted : November 1, 2013
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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 or disease |
|---|
| Ovarian Cancer Hypodontia Breast Cancer Colon Cancer |
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Case Control |
| Time Perspective: | Retrospective |
| Official Title: | Hypodontia and Ovarian Cancer - the Connection Between Dental Agenesis and Epithelial Cancers, Especially Ovarian Cancer. |
| Study Start Date : | September 2011 |
| Estimated Primary Completion Date : | September 2014 |
| Estimated Study Completion Date : | August 2015 |
| Group/Cohort |
|---|
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Ovarian Cancer
Women treated for ovarian cancer at the departments of obstetrics and gynecology, Aarhus University Hospital and Rigshospitalet, Copenhagen. Expected recruitment: 200 |
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Control patients
Women referred to the departments of obstetrics and gynecology in Aarhus University Hospital and Rigshospitalet, Copenhagen on benign indication. Expected recruitment: 200. |
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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. |
- Prevalence rates of hypodontia in women with ovarian cancer [ Time Frame: one year ]
- Genetic causes for hypodontia and ovarian cancer [ Time Frame: two years ]
- Prevalence rates of hypodontia in patients with a known risk for epithelial cancer [ Time Frame: one year ]
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- confirmed suspicion of ovarian cancer.
Exclusion Criteria:
- suspicion of ovarian cancer disproved.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470235
| 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 |
| 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 | |
| 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 |
Publications:
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01470235 History of Changes |
| Other Study ID Numbers: |
Hypodontovariancancer2011 |
| First Posted: | November 11, 2011 Key Record Dates |
| Last Update Posted: | November 1, 2013 |
| Last Verified: | October 2013 |
Keywords provided by University of Aarhus:
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screening genetic cancer |
Additional relevant MeSH terms:
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Ovarian Neoplasms Anodontia Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Tooth Abnormalities Stomatognathic System Abnormalities Stomatognathic Diseases Tooth Diseases Congenital Abnormalities |