Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jacqueline Louwers
ORCID ID
Contact details
Vrije Universiteit Medical Centre (VUMC)
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 4833
ja.louwers@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
The DySIS™ study
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.
Ethics approval
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).
Study design
Non-randomised, controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
10/04/2007
Overall trial end date
10/10/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
400
Participant 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
Recruitment start date
10/04/2007
Recruitment end date
10/10/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije Universiteit Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
VU University Medical Centre (The Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
VU University Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Forth-Photonics (Greece)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary