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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR933 |
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Date of registration:
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13/03/2007 |
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Primary sponsor: |
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Public title:
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An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS? compared to conventional colposcopy`.
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Scientific title:
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An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS? compared to conventional colposcopy. - The DySIS? study |
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Date of first enrolment:
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10/4/2007 |
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Target sample size:
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400 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=933 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, non-randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Jacqueline
Louwers |
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Address:
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VU medisch centrum
Postbus 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+ 31 (0)20 4444833 |
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Email:
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ja.louwers@vumc.nl |
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Affiliation:
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Name:
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Jacqueline
Louwers |
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Address:
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VU medisch centrum
Postbus 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+ 31 (0)20 4444833 |
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Email:
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ja.louwers@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Female;
2. 18 years of age or older;
3. Intact cervix (no history of LEEP or surgical treatment involving damage to the transformation zone of the cervix);
4. Study group only: An abnormal cytological test result and/or positive hrHPV test;
5. Control group only: To be able to undergo a colposcopy (according to the gynecologist);
6. Sufficient knowledge of the Dutch or English language;
7. Able to understand the content of the study (according to the gynecologist);
8. Signed informed consent form.
Exclusion criteria: 1. History of surgery on the cervix;
2. Previous pelvic radiotherapy;
3. Pregnancy or pregnant in the last 3 months;
4. Breast-feeding, or breast-feeding in the last 3 months;
5. Heavy bleeding (menstruation or other) or excessive vaginal discharge in which a colposcopy cannot be performed. Enrolment in the study protocol will be postponed until the condition is resolved according to the gynecologist?s medical judgment;
6. Self-referring women without an abnormal smear.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Cervical intraepithelial neoplasia (CIN), Digital colposcopy, Human papillomavirus
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Intervention(s)
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1. Besides conventional colposcopy, colposcopy with DySIS.
2. hrHPV, viral load, E6/E7 antibodies and p16INK4a testing.
3. At random biopsy.
4. Measurement of the lesion size.
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Primary Outcome(s)
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Primary endpoint:
Consensus in DySIS colposcopic and conventional colposcopic impression of a lesion and histology (?golden standard?).
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Secondary Outcome(s)
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Secondary endpoints:
1. Consensus in DySIS colposcopic and conventional colposcopic localization of the optimal biopsy point and histology (?golden standard?).
2. Consensus of DySIS colposcopic and conventional colposcopic impression of a lesion and HPV GP5+/6+ PCR testing and hybrid capture.
3. Higher HPV viral load by a larger, hrHPV positive, lesion (through (semi-)quantitative, real-time PCR-based viral load assessment).
4. A relation between p16INK4a and the size of the lesion.
5. A relation between viral load and hrHPV antibody titers.
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Secondary ID(s)
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ISRCTN66112760
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N/A
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Source(s) of Monetary Support
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VU University Medical Center, Forth-Photonics
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