Clinical trial · Interventional
Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1
Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1
NCT00156026CI-TRIAL-00001947completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| loop electrosurgical excision procedure (LEEP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Immediate Treatment - LEEP - Loop electrosurgical excision procedure
- interventionNames
- Procedure: loop electrosurgical excision procedure (LEEP)
- type
- NO_INTERVENTION
- label
- 2
- description
- Colposcopic Follow-up
Primary outcomes (1)
- measure
- progression to more advanced disease
- timeFrame
- 18 months
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible patients will: * have documented CIN 1 by histologic assessment as the highest grade lesion present, * have the lesion confined to the cervix and completely visualized, * be 16 years or older. Exclusion Criteria: * any one of the following will be an excluding characteristic: * index Pap smear showing CIN 2, CIN 3 or cancer; * index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia, or malignancy requiring immediate investigation; * patients with previously identified CIN 1 by biopsy who are already in a colposcopic surveillance program; * 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; * pregnancy; * prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy; * prior gynecologic cancer; * prior pelvic radiation therapy; * inability to attend outpatient follow-up visits because of geographic inaccessibility; * other malignancies except non-melanoma skin cancer; * immunosuppression due to diseases such as AIDS, organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus; * cognitively impaired or otherwise unable to obtain written informed consent; * extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia; * colposcopically visible condyloma outside of the transformation zone; * known allergy to local analgesics; * clinically evident vaginitis must be treated and resolved prior to entry on the trial; * inability to read and respond in English/French; * failure to provide informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.