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Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1

Phase 3
16 Years
Not Enrolling
Cervical Intraepithelial Neoplasia

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Trial Information

Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1

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).

Inclusion Criteria:

- Eligible patients will:

- have documented CIN 1 by histologic assessment as the highest grade lesion

- 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

- prior gynecologic cancer;

- prior pelvic radiation therapy;

- inability to attend outpatient follow-up visits because of geographic

- 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

- 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

- inability to read and respond in English/French;

- failure to provide informed consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression to more advanced disease

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Laurie Elit, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Juravinski Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

November 2000

Completion Date:

September 2007

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • CIN 1
  • cervical intraepithelial neoplasia
  • cervix
  • cancer
  • loop electrosurgical excision procedure
  • LEEP
  • expectant management
  • human papilloma virus
  • HPV
  • colposcopy
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ