| - candidate number | 2518 |
| - NTR Number | NTR933 |
| - ISRCTN | ISRCTN66112760 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 13-mrt-2007 |
| - Secondary IDs | N/A |
| - Public Title | An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS™ compared to conventional colposcopy`. |
| - Scientific Title | An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS™ compared to conventional colposcopy. |
| - ACRONYM | The DySIS™ study |
| - hypothesis | Primary: DySIS has a higher sensitivity in discriminating high grade (HG) from low grade (LG) lesions and non neoplastic tissue as well as in selecting the most atypical site for biopsy sampling, through digital documentation and interpretation of colposcopic images and the correlation with visual interpretation and histology (‘golden standard’) than conventional colposcopy. |
| - Healt Condition(s) or Problem(s) studied | Cervical intraepithelial neoplasia (CIN), Digital colposcopy, Human papillomavirus |
| - 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. |
| - mec approval received | no |
| - multicenter trial | yes |
| - randomised | no |
| - group | Parallel |
| - Type | 2 or more arms, non-randomized |
| - Studytype | intervention |
| - planned startdate | 10-apr-2007 |
| - planned closingdate | 10-okt-2007 |
| - Target number of participants | 400 |
| - Interventions | 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. |
| - Primary outcome | Primary endpoint: Consensus in DySIS colposcopic and conventional colposcopic impression of a lesion and histology (‘golden standard’). |
| - Secondary outcome | 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. |
| - Timepoints | N/A |
| - Trial web site | http://www.humavac.nl (onder 'onderzoek') |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | MD Jacqueline Louwers |
| - CONTACT for SCIENTIFIC QUERIES | MD Jacqueline Louwers |
| - Sponsor/Initiator | VU University Medical Center, Forth-Photonics |
| - Funding (Source(s) of Monetary or Material Support) | VU University Medical Center, Forth-Photonics |
| - Publications | N/A |
| - Brief summary | Rationale: DySIS™, developed by Forth-Photonics, is an abbreviation for Dynamic Spectral Imaging System. With this system it is possible to digitally evaluate and save colposcopic images. The use of this kind of techniques for optical and digital detection of CIN lesions seems promising. Objectives: Primary: - To validate the latest version of DySIS in discriminating high grade (HG) from low grade (LG) lesions and non neoplastic tissue as well as in selecting the most atypical site for biopsy sampling, through digital documentation and interpretation of colposcopic images and the correlation with visual interpretation and histology (‘golden standard’). Secondary: - To validate the latest version of DySIS in reducing both inter- and intra- observer disagreement. - To investigate (feasibility study) the ability of DySIS to identify hrHPV-positive lesions by correlating dynamic optical parameters and lesion’s size measured both with DySIS, with HPV GP5+/6+ PCR testing, hybrid capture and (semi-) quantitative viral load assessment. - To demonstrate the correlation between the size of a cervical lesion and hrHPV viral load through correlation of colposcopic images with viral parameters (i.e. hybrid capture, GP5+/6+ HPV testing and (semi-) quantitatively viral load assessment). - Comparison of the performances of conventional colposcopy and DySIS in in-vivo identifying hrHPV-positive cervical lesions, using HPV typing and histology as a reference. - Correlation of the size of a cervical lesion and p16INK4a expression. - To demonstrate the relation between viral load ((semi-)quantitative assessment) and hrHPV antibodies. Study design: Subjects will be recruited at the Gynaecological outpatient clinic of the VU university medical center (Amsterdam) or Reinier de Graaf Groep (Voorburg), among women referred for colposopy because of an abnormal pap test result or positive hrHPV test. Besides this group, a control group will be formed. Before colposcopy, a liquid based cervical sample will be collected for HPV detection. Subsequently, colposcopy with the use of DySIS and a conventional colposcopy will be performed. When applicable, biopsies will be taken from suspicious areas on the cervix. From all subjects one ‘at random’ biopsy will taken. Finally, a blood sample will be taken for HPV antibody detection. Study population: Women of 18 years and older, who are referred for colposcopy because of an abnormal pap smear result or positive hrHPV test. A group of women with the same characteristics as the study group, but without an abnormal pap test result or positive hrHPV test in the last 5 years, will be recruited as a control group. Endpoints: Primary endpoint: - Consensus in DySIS colposcopic and conventional colposcopic impression of a lesion and histology (‘golden standard’). Secondary endpoints: - Consensus in DySIS colposcopic and conventional colposcopic localization of the optimal biopsy point and histology (‘golden standard’). - Consensus of DySIS colposcopic and conventional colposcopic impression of a lesion and HPV GP5+/6+ PCR testing and hybrid capture. - Higher HPV viral load by a larger, hrHPV positive, lesion (through (semi-)quantitative, real-time PCR-based viral load assessment). - A relation between p16INK4a and the size of the lesion. - A relation between viral load and hrHPV antibody titers. Risks and burden for the study subjects Risks and burden are linked to the protocol procedures, such as a cervical biopsy and taking a blood and cervical sample. Although these are routine procedures, carried out by medically qualified personnel, they may cause side effects or discomfort to the subjects. However, it is expected that these procedures will generally be well tolerated. |
| - Main changes (audit trail) | |
| - RECORD | 13-mrt-2007 - 13-jan-2010 |
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