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
Protocol serial number	N/A
Sponsor	VU University Medical Centre (The Netherlands)
Funders	VU University Medical Centre (The Netherlands), Forth-Photonics (Greece)

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

Vrije Universiteit Medical Centre (VUMC)
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 4833
Email	ja.louwers@vumc.nl

Study information

Primary study design	Interventional
Study design	Non-randomised, controlled, parallel group, multicentre trial
Secondary study design	Non randomised controlled trial
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(s)	Primary endpoint: Consensus in DySIS™ colposcopic and conventional colposcopic impression of a lesion and histology (golden standard).
Key secondary outcome measure(s)	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
Completion date	10/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/01/2021: Publication reference added.