A Phase 3 interventional study of loop electrosurgical excision procedure (LEEP) in Cervical Intraepithelial Neoplasia, sponsored by Ontario Clinical Oncology Group (OCOG). Completed at 10 sites in 2 countries. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-01-29.
Sponsored by Ontario Clinical Oncology Group (OCOG) · Phase 3, Interventional, and Treatment
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.
In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 415 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Ontario Clinical Oncology Group (OCOG) is the lead sponsor of 56 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible patients will:
Exclusion Criteria:
any one of the following will be an excluding characteristic:
Immediate Treatment - LEEP - Loop electrosurgical excision procedure
Procedure: loop electrosurgical excision procedure (LEEP)
Colposcopic Follow-up
1. loop electrosurgical excision procedure
progression to more advanced disease
Time frame: 18 months
persistent CIN 1 after 18 months
Time frame: 18 months
bleeding.
Time frame: 18 months
predict disease persistence or progression
Time frame: 18 months
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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Ontario Clinical Oncology Group (OCOG)