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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28477

Enrollment

400

Registered

2007-03-13

Start date

2007-04-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital colposcopy (Digitale colposcopie) Human papillomavirus (Humaan papillomavirus) Cervical Intraepithelial Neoplasia (CIN) (Cervicale Intraepitheliale Neoplasie (CIN))

Interventions

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.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female; 2. 18 years of age or older; 3. Intact cervix (no history of 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 hrHPV test; 5. Control group only: To be able to undergo a colposcopy (according to the gynecologist); 6. Sufficient knowledge of the Dutch or English language; 7. Able to understand the content of the study (according to the gynecologist); 8. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of surgery on the cervix; 2. Previous pelvic radiotherapy; 3. Pregnancy or pregnant in the last 3 months; 4. Breast-feeding, or breast-feeding in the last 3 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 gynecologist’s medical judgment; 6. Self-referring women without an abnormal smear.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Consensus in DySIS colposcopic and conventional colposcopic impression of a lesion and histology (‘golden standard’).	—

Secondary

Measure	Time frame
Secondary endpoints: 1. Consensus in DySIS colposcopic and conventional colposcopic localization 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+ 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 titers.	—

Measure

Time frame

Secondary endpoints: 1. Consensus in DySIS colposcopic and conventional colposcopic localization 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+ 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 titers.

—

Contacts

Public ContactJacqueline Louwers

VU medisch centrum Postbus 7057

ja.louwers@vumc.nl+ 31 (0)20 4444833

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)