Randomized trial of immediate treatment versus colposcopic followup for biopsy-proven cervical intraepithelial neoplasia (CIN) 1

Not Applicable

Completed

• Conditions: Preinvasive Cervical Disease; Cancer; Cervical

• Registration Number: ISRCTN91252554
• Lead Sponsor: McMaster University (Canada) - Faculty of Health Sciences

Brief Summary

2011 results in https://pubmed.ncbi.nlm.nih.gov/21425144/ (added 12/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-26
• Study Completion: 2007-09-30
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 415

Inclusion Criteria

1. Documented CIN 1 by histologic assessment as the highest grade lesion present
2. Lesion confined to the cervix and completely visualized
3. Be 16 years or older, female

Exclusion Criteria

Among patients satisfying the inclusion criteria the following will be excluding characteristics:
1. Index Pap smear showing CIN 2, 3 or cancer:
1.1. Index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia or malignancy requiring immediate investigation
1.2. Patients with previously identified CIN 1 by biopsy who are already in a surveillance program
2. Unsatisfactory colposcopic exam defined as inability to see the extent of the lesion in the endocervical canal or absence of a lesion on the ectocervix but endocervical curettage shows CIN 1
3. Pregnancy
4. Prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy
5. Prior gynecologic cancer
6. Prior pelvic radiation therapy
7. Inability to attend outpatient followup visits because of geographic inaccessibility
8. Other malignancies except non-melanoma skin cancer
9. Immunosuppression due to diseases such as Acquired Immune Deficiency Syndrome (AIDS), organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus
10. Cognitively impaired or otherwise unable to obtain written informed consent
11. Extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia
12. Colposcopically visible condyloma outside of the transformation zone
13. Known allergy to local analgesics
14. Clinically evident vaginitis must be treated and resolved prior to entry on the trial
15. Inability to read and respond in English
16. Failure to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified