Condition category
Cancer
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
17/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.humavac.nl (onder 'onderzoek')

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 gynaecologist’s 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

http://www.vumc.nl/english/#http://www.vumc.nl/english/

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

Publication citations

Additional files

Editorial Notes