An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS™ compared to conventional colposcopy

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN66112760
• Date of registration: 11/04/2007
• Prospective Registration: No
• Primary sponsor: VU University Medical Centre (The Netherlands)
• Public title: An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS™ compared to conventional colposcopy
• Date of first enrolment: 10/04/2007
• Target sample size: 400
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN66112760
• Study type: Interventional
• Study design: Non-randomised, controlled, parallel group, multicentre trial (Treatment)

Countries of recruitment

Netherlands

Contacts

• Name: Jacqueline Louwers

Key inclusion & exclusion criteria

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
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 gynaecologist?s medical judgment
6. Self-referring women without an abnormal smear

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Intraepithelial Neoplasia (CIN)
Cancer
Neoplasia

Intervention(s)

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.

Primary Outcome(s)

Primary endpoint:
Consensus in DySIS™ colposcopic and conventional colposcopic impression of a lesion and histology (?golden standard?).

Secondary Outcome(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

Secondary ID(s)

N/A

Source(s) of Monetary Support

VU University Medical Centre (The Netherlands), Forth-Photonics (Greece)