Identification of the value of a novel test for the surveillance of women with precancerous lesions of the cervix who wish to avoid surgical treatment

Surveillance of Cervical Intraepithelial Neoplasia (CIN) grade 2 with Dual P16/Ki-67 Immunocytochemistry staining

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN56383373

Enrollment

100

Registered

2023-10-30

Start date

2023-04-30

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

Timely diagnosis of Cervical Intraepithelial Neoplasia (CIN) grade 3 or worse in women with CIN2 who opt for no treatment. Urological and Genital Diseases

Interventions

According to the study design, women with Cervical Intraepithelial Neoplasia (CIN) grade 2 at t=0 will be tested for p16/Ki-67 immunocytochemistry (ICC) with the CINtec Plus Cytology test and high-ris

Eligibility

Sex/Gender

Female

Age

21 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Women referred to the Unit of Colposcopy and Cervical Pathology, Department of Gynaecological Oncology, 1st Department of Obstetrics and Gynaecology, “Papageorgiou” General Hospital, Thessaloniki, Greece. 2. Reason for referral: 2.1. Abnormal pap test (ASCUS or worse) 2.2. hrHPV positivity in cervical samples 2.3. Histologic diagnosis of CIN 1 or 2 3. Of these women those with a final diagnosis of CIN2, who do not wish to be subjected to excision cervical procedure, are eligible to be included in the analysis. 4. Age range: 21-65 years old

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Inability to adequately communicate 3. Inability to comply with the required follow-up during the study 4. Recurrent or acute vaginitis 5. Taking systemic immunosuppressive or immunomodulatory treatment (methotrexate, glucocorticoids, non-steroidal anti-inflammatory drugs, etc.) 6. CIN3 7. Cancer 8. Chemotherapy 9. Radiotherapy

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of CINtec Plus Cytology is measured using sensitivity and positive predictive value of the test for the diagnosis of CIN2+ and CIN3+ at 6, 12, 18, and 24 months after recruitment.	—

Secondary

Measure	Time frame
Diagnostic accuracy of Liquid-based Cytology is measured using sensitivity and positive predictive value of the test for the diagnosis of CIN2+ and CIN3+ at 6, 12, 18, and 24 months after recruitment.	—

Countries

Greece

Contacts

Public ContactKimon;Dimitrios Chatzistamatiou;Tsolakidis

;

kimonch@auth.gr;dtgyn@otenet.gr+30 6973321162;+30 6944517951

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026