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

Not Applicable

• 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

• Registration Number: ISRCTN56383373
• Lead Sponsor: Papageorgiou General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-30
• Last Update Posted: 13 November 2023
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified