A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women

NCT02250716 | Unknown

• 1 other identifier: CIN1
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

Based on the high incidence of cervical cancer and high grade dysplasia and increased progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have had a colposcopic biopsy for persistent LSIL as per standard of care.

Conditions

Cervical Dysplasia

Keywords

CIN1; HIV seropositive women; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Regresson of CIN1 to a normal biopsy

  Treatment failure is the progression of CIN1 to CIN2

  12 month

Study Arms (2)

Arm 1

EXPERIMENTAL

Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up

Procedure: cryotherapy

Arm 2

NO INTERVENTION

12 month cytology and histology follow-up

Interventions

cryotherapy PROCEDURE

cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV -infected women whose biopsy proves CIN1 and who consent to study participants and procedures
• CIN1 with no visible lesion
• The entire ectocervical lesion should cover less than 75% of the cervix and not more than 2 - 3mm into the endocervical canal

You may not qualify if:

• Pregnant women
• Known and previous treatment for HSIL by any method (Cryotherapy, LEEP or cone biopsy)
• Women who are menstruating or who have active pelvic inflammatory disease will be deferred from the study until the infection is cleared or the menstrual cycle has ended; the patient may then participate in the study.
• Unsatisfactory colposcopic examination defined as inability to see the extent of the lesion in the endocervical canal and lesions deemed ineligible for cryotherapy by an OB/GYN specialist.
• Previous hysterectomy with removal of the cervix

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

Study Sites (1)

University of Witwatersrand/Helen Joseph Hospital

Johannesburg, South Africa

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Cynthia S Firnhaber, MD

  University of Witwatersrand, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: October 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

ZA (1)