Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233727
Status:
TERMINATED
Last Update Posted:
2015-07-09
First Post:
2005-10-04
Brief Title:
Screen and Treat for Cervical Cancer Prevention
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Safety and Efficacy of Two Screen-and-Treat Approaches for the Prevention of Cervical Cancer
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left University
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAT
Brief Summary:
The study measures the impact of screen-and-treat on the prevalence of high-grade cervical intraepithelial neoplasia and cancer CIN 2 It is a three-arm randomized clinical trial comparing two screen-and-treat approaches to delayed evaluation as a control The primary outcome is biopsy-confirmed CIN 2 at 6 months and significant complications within 6 months of randomization with continued follow-up to detect CIN2 and other complications up to 36 months post-randomization
Detailed Description:
Participants and Clinical Examinations Unscreened non-pregnant women 35-65 years of age are enrolled at three closely located clinical sites in Khayelitsha South Africa All women provide informed consent receive counseling for confidential HIV serotesting a questionnaire a pregnancy test if not postmenopausal anonymous HIV serotesting and a vaginal speculum examination by nurses trained in visual inspection of the cervix with acetic acid VIA Cervical specimens are obtained for testing for N gonorrhea Chlamydia trachomatis and high-risk types of HPV and cytology The cervix is washed with 5 acetic acid and inspected for gross abnormalities or areas of acetowhitening and a 35 mm photograph taken Women with significant cervicitis or vulvovaginitis are treated using the syndromic approach N gonorrhea or Chlamydia trachomatis positive women receive appropriate therapy A positive VIA examination is defined as any acetowhite lesion and no attempt is made to differentiate the acetowhitening of metaplasia from CIN Women with lesions suspicious for cancer large acetowhite lesions extending over 70 of the cervix or into endocervical canal and 374 unsuitable for cryotherapy due to severe atrophy polyps cervix distorted cervix not adequately visualized are excluded These women are referred to colposcopy
Women are asked to return 2-6 days later for randomization to either 1 HPV arm in which all HPV DNA positive women receive cryotherapy 2 VIA arm in which all VIA positive women receive cryotherapy and 3 a delayed evaluation arm in which women are followed untreated irrespective of HPV or VIA status Randomization is done at a patient level using a computer-generated randomization schedule with arm assignments provided to the clinics in sealed envelopes Cryotherapy is performed by a nurse using N2O and a cryosurgical unit Wallach Surgical Devices Orange CT using two 3-minute freezes Cytology results are not available at the time of cryotherapy Both treated and untreated women are asked to return at 4 weeks for a questionnaire
At 6 months colposcopy is done by a physician blinded to arm and clinical information All acetowhite lesions are biopsied and all have an endocervical curettage Women with CIN 2 are treated with LEEP Examinations in women who became pregnant during the study are postponed until three months post-partum Blood for anonymous HIV serotesting is obtained All women who were HPV or VIA-positive at enrollment and a subset who were HPV and VIA-negative all women enrolled in 2002 are scheduled for repeat colposcopy at 12 months 24 months and 36 months post-randomization At these visits cervical samples are collected and colposcopy and biopsy if indicated is performed
Laboratory Testing HPV testing is done using the Hybrid Capture 2 HPV DNA assay and high-risk probe mixture Digene Corporation Gaithersburg MD at the University of Cape Town Biopsies are processed at Columbia University and blindly evaluated by a single pathologist
Women are asked to return 2-6 days later for randomization to either 1 HPV arm in which all HPV DNA positive women receive cryotherapy 2 VIA arm in which all VIA positive women receive cryotherapy and 3 a delayed evaluation arm in which women are followed untreated irrespective of HPV or VIA status Randomization is done at a patient level using a computer-generated randomization schedule with arm assignments provided to the clinics in sealed envelopes Cryotherapy is performed by a nurse using N2O and a cryosurgical unit Wallach Surgical Devices Orange CT using two 3-minute freezes Cytology results are not available at the time of cryotherapy Both treated and untreated women are asked to return at 4 weeks for a questionnaire
At 6 months colposcopy is done by a physician blinded to arm and clinical information All acetowhite lesions are biopsied and all have an endocervical curettage Women with CIN 2 are treated with LEEP Examinations in women who became pregnant during the study are postponed until three months post-partum Blood for anonymous HIV serotesting is obtained All women who were HPV or VIA-positive at enrollment and a subset who were HPV and VIA-negative all women enrolled in 2002 are scheduled for repeat colposcopy at 12 months 24 months and 36 months post-randomization At these visits cervical samples are collected and colposcopy and biopsy if indicated is performed
Laboratory Testing HPV testing is done using the Hybrid Capture 2 HPV DNA assay and high-risk probe mixture Digene Corporation Gaithersburg MD at the University of Cape Town Biopsies are processed at Columbia University and blindly evaluated by a single pathologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None