A Randomized Controlled Trial to Evaluate the Efficacy of a Dual-Modality Immunotherapy (Oral Immunomodulator and Vaginal Ovule) for Human Papillomavirus (HPV) Clearance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- HPV clearance rate
研究概览
简要总结
Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.
详细描述
Persistent high-risk human papillomavirus infection is a major risk factor for cervical intraepithelial neoplasia and cervical cancer. Although many infections regress spontaneously, persistent infection may require close surveillance, and non-invasive therapeutic strategies that may enhance host immune response and promote viral clearance remain clinically relevant.
This is a prospective, single-center, randomized, assessor-blinded, parallel-group controlled trial conducted at the Department of Gynecologic Oncology of Kartal Dr. Lutfi Kirdar City Hospital.
A total of 76 participants will be randomized in a 1:1 ratio using a computer-generated allocation sequence, with 38 participants assigned to each group. Treatment allocation will be managed by an unblinded study team member. Outcome assessors will remain blinded to group assignment.
Participants in the intervention arm will receive an oral immunomodulator twice daily together with a vaginal ovule administered for 14 consecutive days each month for 3 months. Participants in the control arm will receive standard supportive care.
Eligible participants must have confirmed HPV positivity with low-grade cervical abnormalities, including ASC-US, LSIL, or CIN 1, and must not require an invasive cervical procedure such as biopsy, colposcopy-directed treatment, or LEEP during the 3-month study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors evaluating HPV test and cervical cytology results are blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-65 years.
- •Confirmed persistent high-risk human papillomavirus (HR-HPV) infection.
- •Histologically confirmed CIN 1 or cytological diagnosis of ASC-US or LSIL.
- •Eligible for conservative follow-up without immediate excisional treatment.
- •Ability to provide written informed consent and comply with study procedures.
排除标准
- •HSIL, CIN2, CIN3, adenocarcinoma in situ, or invasive cervical cancer.
- •Pregnancy or breastfeeding.
- •Immunodeficiency or current immunosuppressive therapy.
- •Previous treatment for cervical dysplasia within the last 6 months.
- •Planned colposcopy, cervical biopsy, or LEEP during the 3-month study period.
- •Known hypersensitivity to any study intervention.
- •Participation in another interventional clinical trial.
结局指标
主要结局
HPV clearance rate
时间窗: 3 months
The proportion of participants with a negative high-risk HPV test at the end of the 3-month treatment period.
次要结局
- Cytological regression(3 months)
研究者
Özge Nur Gülen
Gynecologic Oncology Fellow
Dr. Lutfi Kirdar Kartal Training and Research Hospital