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Genetics of pelvic organ prolapse; identification of specific gene defects in patients and their family members.


- candidate number6282
- NTR NumberNTR1935
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2009
- Secondary IDs2009/067 CMO Regio Arnhem-Nijmegen
- Public TitleGenetics of pelvic organ prolapse; identification of specific gene defects in patients and their family members.
- Scientific TitleGenetics of pelvic organ prolapse; identification of specific gene defects in patients and their family members.
- ACRONYMGenetics of pelvic organ prolapse
- hypothesisThe COL3A1 polymorphism is a inheritable genetic defect, responsible for the increased susceptibility to pelvic organ prolapse in women.
- Healt Condition(s) or Problem(s) studiedPelvic floor function, Collagen, Genetic polymorfism, Pelvic organ prolaps
- Inclusion criteriaFirst and second degree relatives of patients with COL3A1 polymorphism.
- Exclusion criteria1. Genetic diseases with a known increased risk of POP (such as Ehlers Danlos, Marfan and Steinertís disease);
2. Problems with regards to the patientís understanding of the study;
3. Age < 18 years.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 22-jun-2009
- planned closingdate1-jan-2012
- Target number of participants50
- InterventionsNone.
- Primary outcomeThe presence of the COL3A1 polymorphism in first and second degree family members of the index patients with the homozygous COL3A1 polymorphism.
- Secondary outcomeThe presence of pelvic organ prolapse and related conditions (such as inguinal hernia) in first and second degree family members of the index patients with the homozygous COL3A1 polymorphism.
- Timepoints1. A blood sample of all subjects will be used for the detection of the COL3A1 polymorphism by means of PCR followed by RFLP analysis;
2. Prolapse will be assessed by gynaecological investigation of female subjects to complete the POP-Q;
3. Other related conditions will be evaluated by means of a qestionnaire.
- Trial web siteN/A
- status[default]
- CONTACT FOR PUBLIC QUERIES S.L. Lince
- CONTACT for SCIENTIFIC QUERIES S.L. Lince
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryType III collagen is of special importance in tissue repair following mechanical stretch such as in delivery or pelvic organ prolapse (POP). Type III collagen polymorphisms may therefore result in a decrease in tissue repair and may lead to impaired tensile strength of ligaments and supportive tissues. Chen and co-workers have suggested that a COL3A1 polymorphism in exon 30 was related to POP in Taiwanese women. Our research group recently confirmed this finding in a larger population of 202 Dutch POP patients and 102 parous controls. The odds ratio for the presence of POP in a woman with this homozygous COL3A1 polymorphism is 5.0 (95% confidence interval 1.4; 17.1).

Our hypothesis is that the COL3A1 polymorphism is a inheritable genetic defect, responsible for increased familial susceptibility to pelvic organ prolapse and other collagen-mediated diseases.
- Main changes (audit trail)
- RECORD5-aug-2009 - 11-okt-2009


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