Phase
Condition
Neoplasms
Precancerous Condition
Genitourinary Cancer
Treatment
N/AClinical Study ID
Ages > 16 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Eligible patients will:
have documented CIN 1 by histologic assessment as the highest grade lesionpresent,
have the lesion confined to the cervix and completely visualized,
be 16 years or older.
Exclusion
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, glandulardysplasia, or malignancy requiring immediate investigation;
patients with previously identified CIN 1 by biopsy who are already in acolposcopic surveillance program;
unsatisfactory colposcopic exam defined as inability to see the extent of thelesion in the endocervical canal or absence of a lesion on the ectocervix butendocervical curettage shows CIN 1;
pregnancy;
prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) orcryotherapy;
prior gynecologic cancer;
prior pelvic radiation therapy;
inability to attend outpatient follow-up visits because of geographicinaccessibility;
other malignancies except non-melanoma skin cancer;
immunosuppression due to diseases such as AIDS, organ transplantation, or onimmunosuppressive medications such as prednisone, imuran or chemotherapy fordiseases 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 showingdysplasia;
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 thetrial;
inability to read and respond in English/French;
failure to provide informed consent.
Study Design
Study Description
Connect with a study center
Universidade Estadual de Campinas
Campinas, CEP 13083-970
BrazilSite Not Available
Instituto Fernandes Figueira - Oswaldo Cruz Foundation
Rio de Janeiro, CEP 22250-020
BrazilSite Not Available
B.C. Cancer Agency
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
Nova Scotia Cancer Centre
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
Brantford General Hospital
Brantford, Ontario N3T 3J2
CanadaSite Not Available
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario L8P 3A9
CanadaSite Not Available
London Health Sciences Centre
London, Ontario N6A 4G5
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
University of Saskatchewan
Saskatoon, Saskatchewan S7K 3H3
CanadaSite Not Available
Hôpital du Saint-Sacrement
Quebec, G1S 2L6
CanadaSite Not Available
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