An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS™ compared to conventional colposcopy
| ISRCTN | ISRCTN66112760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66112760 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 05/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jacqueline Louwers
Scientific
Scientific
Vrije Universiteit Medical Centre (VUMC)
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 4833 |
|---|---|
| ja.louwers@vumc.nl |
Study information
| Study design | Non-randomised, controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS™ compared to conventional colposcopy |
| Study acronym | The DySIS™ study |
| Study objectives | 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. |
| Ethics approval(s) | The protocol of the DySIS study was approved on 6th July 2007 by the local medical ethics committee (Medisch Ethische Toetsingscommissie VU medisch centrum) in Amsterdam, The Netherlands (ref:2007/098). |
| Health condition(s) or problem(s) studied | Cervical Intraepithelial Neoplasia (CIN) |
| Intervention | 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 For all the subjects, all the measurements are done during one visit to the outpatient clinic. Therefore, the primary and secondary outcomes are also measured during this visit. |
| Intervention type | Other |
| Primary outcome measure | Primary endpoint: Consensus in DySIS™ colposcopic and conventional colposcopic impression of a lesion and histology (golden standard). |
| Secondary outcome measures | Secondary endpoints: 1. Consensus in DySIS™ colposcopic and conventional colposcopic localisation 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+ Polymerase Chain Reaction (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 titres |
| Overall study start date | 10/04/2007 |
| Completion date | 10/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Female 2. 18 years of age or older 3. Intact cervix (no history of Loop Electrosurgical Excision Procedure [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 high-risk Human Papillomavirus (hrHPV) test 5. Control group only: to be able to undergo a colposcopy (according to the gynaecologist) 6. Sufficient knowledge of the Dutch or English language 7. Able to understand the content of the study (according to the gynaecologist) 8. Signed informed consent form |
| Key exclusion criteria | 1. History of surgery on the cervix 2. Previous pelvic radiotherapy 3. Pregnancy or pregnant in the last three months 4. Breast-feeding, or breast-feeding in the last three 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 gynaecologists medical judgment 6. Self-referring women without an abnormal smear |
| Date of first enrolment | 10/04/2007 |
| Date of final enrolment | 10/10/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije Universiteit Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
VU University Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Website | http://www.vumc.nl/english/#http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Industry
VU University Medical Centre (The Netherlands)
No information available
Forth-Photonics (Greece)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2015 | 04/01/2021 | Yes | No |
Editorial Notes
04/01/2021: Publication reference added.
