Trial Outcomes & Findings for Thermocoagulation for Treatment of Precancerous Cervical Lesions (NCT NCT04191967)

NCT ID: NCT04191967

Last Updated: 2023-01-25

Results Overview

The proportion of participants with no evidence of cervical dysplasia at 12-months follow-up, defined as biopsy-confirmed CIN1 result or normal findings, 12-months following treatment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 379 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-01-25

Participant Flow

Between August 2019 and February 2020, women enrolled in care at Fostering Advances through Collaboration, Education & Sciences (FACES)- supported HIV clinics in western Kenya were recruited to the study.

All participants received cervical cancer screening using human papillomavirus (HPV) testing. Participants with positive results received a biopsy and then proceeded to same-day treatment. Thermocoagulation candidates must have a fully visualized, squamocolumnar junction, cervical lesions (if present) covering < 75% of cervix, and no endocervical component of lesion, or suspicion for cancer. Participants who were not candidates for ablation were referred to a nearby facility.

Participant milestones

Measure	Thermocoagulation Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician. Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Screening & Thermocoagulation (Ablation) STARTED	379
Screening & Thermocoagulation (Ablation) COMPLETED	293
Screening & Thermocoagulation (Ablation) NOT COMPLETED	86
12 Month Follow-up STARTED	58
12 Month Follow-up COMPLETED	54
12 Month Follow-up NOT COMPLETED	4

Reasons for withdrawal

Measure	Thermocoagulation Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician. Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Screening & Thermocoagulation (Ablation) Not considered candidates for thermocoagulation	86
12 Month Follow-up Pathology results for 12 month treatment efficacy not available for these participants	4

Baseline Characteristics

Thermocoagulation for Treatment of Precancerous Cervical Lesions

Baseline characteristics by cohort

Measure	Thermocoagulation n=293 Participants Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician. Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Age, Continuous	40.4 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	293 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	293 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	293 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Kenya	293 participants n=5 Participants
Prior cervical cancer screening	206 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

The proportion of participants with no evidence of cervical dysplasia at 12-months follow-up, defined as biopsy-confirmed CIN1 result or normal findings, 12-months following treatment.

Outcome measures

Measure	Thermocoagulation n=54 Participants Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician.Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months	0.66 proportion of participants

PRIMARY outcome

Timeframe: 12 months

The proportion of persistence of HPV at follow-up will be reported defined as treatment failure with persistent biopsy-confirmed CIN2/3.

Outcome measures

Measure	Thermocoagulation n=54 Participants Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician.Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Proportion of Participants With Persistent HPV at 12-month Follow-up	0.34 proportion of participants

SECONDARY outcome

Timeframe: Day of Treatment, approximately 1 day

A 4-point Visual Analog Scale (VAS) for pain assessment was used to evaluate pain immediately after treatment. The pain VAS was comprised of verbal descriptors, one for each symptom extreme. The pain VAS is self-completed by the respondent. The respondent is asked to select the point that represents their pain intensity. The "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).

Outcome measures

Measure	Thermocoagulation n=293 Participants Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician.Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Frequency of Pain Score Category No pain	15 Participants
Frequency of Pain Score Category Mild pain	231 Participants
Frequency of Pain Score Category Moderate pain	42 Participants
Frequency of Pain Score Category Severe pain	5 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks following treatment

The percentage of participants reporting grade 2 and higher AEs, and severe adverse events (SAEs) during the 4-week follow-up will be reported by event.

Outcome measures

Measure	Thermocoagulation n=293 Participants Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician.Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Percentage of Participants Reporting Treatment-related Adverse Events (AE) Participants with Grade 3 or 4 adverse events	0 percentage of participants
Percentage of Participants Reporting Treatment-related Adverse Events (AE) Pelvic Pain	19.6 percentage of participants
Percentage of Participants Reporting Treatment-related Adverse Events (AE) Bleeding	4 percentage of participants
Percentage of Participants Reporting Treatment-related Adverse Events (AE) Vaginal Discharge	51.2 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 weeks following treatment

Participant satisfaction with thermocoagulation will be evaluated by determining the proportion of participants indicating a response of 'yes' to the question "Do you feel satisfied with the treatment you received?" with an alternative response of 'no' at the 4-6 week follow-up visit.

Outcome measures

Measure	Thermocoagulation n=293 Participants Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician.Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Frequency of Positive Participant Satisfaction Responses	292 Participants

Adverse Events

Thermocoagulation

Serious events: 0 serious events

Other events: 262 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Thermocoagulation n=293 participants at risk Thermal ablation of cervix for treatment of CIN2/3 among HIV-positive participants will be performed by a trained, non-physician clinician.Thermocoagulation will last approximately 20 seconds and will be performed using the Liger Thermocoagulator device
Reproductive system and breast disorders Vaginal hemorrhage	33.8% 99/293 • Up to 12 months Adverse events (AEs) were graded using the Division of AIDS, National Institute of Allergy and Infectious Diseases: Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: Corrected version 2.1. (https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf).
Reproductive system and breast disorders Vaginal discharge	88.1% 258/293 • Up to 12 months Adverse events (AEs) were graded using the Division of AIDS, National Institute of Allergy and Infectious Diseases: Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: Corrected version 2.1. (https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf).
Injury, poisoning and procedural complications Pain (not associated with study agent injections-not specified elsewhere	0.34% 1/293 • Up to 12 months Adverse events (AEs) were graded using the Division of AIDS, National Institute of Allergy and Infectious Diseases: Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: Corrected version 2.1. (https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf).
Reproductive system and breast disorders Pelvic Pain	15.7% 46/293 • Up to 12 months Adverse events (AEs) were graded using the Division of AIDS, National Institute of Allergy and Infectious Diseases: Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: Corrected version 2.1. (https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf).

Additional Information

Dr. Chemtai Mungo, MD, MPH

Univerisity of North Carolina (UNC)

Phone: (984) 974-1000

Email: cmungo@email.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place