Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
2026年9月3日 更新者：Margaret M. Madeleine, PhD、Fred Hutchinson Cancer Center
Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV
Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population.
Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH.
The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe.
This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings.
It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.
研究概览
详细说明
Participants will first undergo HPV testing or visual inspection with acetic acid at screening. Participants with positive screening results undergo a clinical exam comprising visual inspection with acetic acid, digital imaging, brush biopsies of the ectocervix and the endocervix, and assessment for TA treatment. Participants who have a type 1 transformation zone (TZ1) and are otherwise eligible for TA will receive TA with either one or two probes. Screen positive women will be randomized to:
GROUP 1: TA with 1 probe. GROUP 2: TA with 2 probes.
Participants are followed up at 6 months with an HPV test, brush biopsies, and visual assessment of the cervix.
Participants who are not TA eligible will be referred to local care.
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Araceli Loera, MPH
- 电话号码：+1 206-667-5816
- 邮箱：aloera@fredhutch.org
学习地点
-
-
-
Durban、南非
- Centre for the AIDS Programme of Research in South Africa
-
接触：
- Nivashnee Naicker, MBChB, MAS, MPH
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 25-49 years old
- Living with HIV
Inclusion criteria specific to the feasibility study
- Intact cervix
- Willing to return to facility at 6 months
- Willing and able to provide informed consent
- Positive hrHPV or VIA test within 3 months of enrollment
- Type 1 transformation zone (TZ1)
- Thermal ablation eligible
Exclusion Criteria:
- Screened for cervical cancer outside of study in last 6 months
- Currently pregnant or less than 6 weeks postpartum
- Prior diagnosis of cervical cancer
- A history of treatment for cervical precancer
- Total hysterectomy
- Currently receiving treatment for any cancer
- Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study
- Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：第1组（使用1个探头的TA）
参与者接受临床检查、软刷宫颈管和宫颈外口活检、数字成像、TA视觉评估，如果符合条件则在第0个月使用1个探头进行TA。
|
使用1个探头进行TA
|
|
实验性的：第2组（使用2个探头的TA）
参与者接受临床检查、软刷宫颈内和宫颈外活检、数字成像、TA视觉评估，如果符合条件，则在第0个月使用2个探头进行TA。
|
使用2个探头进行TA
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
6个月时持续HPV感染参与者的比例
大体时间：从入组到6个月随访
|
从入组到6个月随访
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Rachel L Winer, PhD, MPH、University of Washington
- 学习椅：Margaret M Madeleine, PhD, MPH、Fred Hutchinson Cancer Center
- 学习椅：Leeya Pinder, MD, MPH、University of Cincinnati
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月15日
初级完成 (估计的)
2027年5月31日
研究完成 (估计的)
2027年5月31日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月12日
研究记录更新
最后更新发布 (实际的)
2026年9月8日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RG1124082 (C1001P-CS9 So Af)
- UG1CA275402 (美国 NIH 拨款/合同)
- U24CA275417 (美国 NIH 拨款/合同)
- 5UG1CA284671-03 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Research data will be shared in a timely manner, with appropriate privacy and confidentiality protections, using the policies and procedures outlined in the NIH Guidelines for Sharing Research Data.
Guidelines, oversight, and requirements for sharing data are based on the institutional policies, IRB rules, and local, state, and federal laws and regulations.
In all cases, the privacy and confidentiality of all people who participate in the research will be protected.
Clinical data on women living with HIV generated during the study will be made available to researchers in both the private and public sector free or for a nominal charge.
IPD 共享时间框架
Deidentified data, the study protocol, and the data dictionary will be made available to qualified investigators within 6 months of acceptance of the manuscript describing major outcomes, for up to 5 years.
IPD 共享访问标准
Requestors will be required to obtain IRB approval and sign a data use agreement before data will be released.
The data use agreement must include the following commitments: a commitment to using the data for research purposes only and not to identify any individual participants; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; and a commitment to meet any additional requirements that might be stipulated by the Biomedical Research Ethics Committee (BREC) or Fred Hutch regulatory review committees or NCI.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.