Clinical Research Directory

RWS of PDT for CIN 2

This is a prospective, observational, multicenter real-world study designed to evaluate the effectiveness and safety of photodynamic therapy (PDT) in women with cervical intraepithelial neoplasia grade 2 (CIN2). Approximately 1,000 women aged 18 to 50 years with biopsy-confirmed CIN2 and a positive human papillomavirus (HPV) test will be enrolled. Participants will receive PDT that is approved for the treatment of CIN2 in routine clinical practice. Treatment will be administered according to the approved product labeling and the treating physician's clinical judgment. As this is an observational real-world study, the number and timing of PDT treatments will not be prespecified and will be recorded according to routine clinical practice. Participants will be followed for 12 months after the initial PDT treatment. The primary outcome is the pathological remission rate at 6 months after the initial PDT treatment. Pathological remission is defined as a cervical biopsy showing normal tissue or CIN1/low-grade squamous intraepithelial lesion (LSIL). Secondary outcomes include HPV clearance rates at 3 and 6 months, the incidence and severity of treatment-related adverse events, and the pathological remission rate at 12 months. Exploratory analyses will evaluate the association between available HPV-related biomarkers, including HPV integration status, and treatment outcomes.

Evaluation of Low-thermal Argon Plasma Devitalization for the Treatment of CIN 2 Versus Standard of Active Surveillance

The study aims to show that treatment with LtAPD works better than a sham treatment or simply monitoring the condition closely without active treatment ("active surveillance"), in achieving complete healing of a tissue abnormality on the cervix called CIN 2, after 6 months. This will be confirmed by examining tissue samples under a microscope (histopathological examination).

HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2

This is a prospective, multicenter real-world study evaluating the effectiveness and safety of hexaminolevulinate photodynamic therapy (HAL-PDT) in patients with cervical intraepithelial neoplasia grade 2 (CIN2). Treatment is guided by colposcopic response: patients receive 2, 3, or 4 sessions of HAL-PDT based on lesion persistence at Day 60 and Day 90 assessments. The primary endpoint is histopathological regression rate at 6 months after first treatment. Secondary endpoints include histopathological regression at 12 months, HPV clearance at 6 and 12 months, and safety. A total of 500 patients will be enrolled.

Digital Telecytology for Triage of HPV-Positive Women in Cameroon

This study evaluates the diagnostic accuracy and feasibility of a same-day cervical cancer screening strategy using HPV self-sampling followed by digital telecytology triage among HPV-positive women in Cameroon. Women aged 30-49 years (or 25-49 years if HIV-positive) will undergo primary HPV testing using the GeneXpert system. HPV-positive women will be managed according to an extended HPV genotyping-based algorithm, including immediate treatment, telecytology triage, or follow-up. Histological assessment serves as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary objectives include evaluation of AI-assisted telecytology and visual inspection with acetic acid (VIA), as well as the acceptability of screening and treatment strategies among women and healthcare providers. The study aims to generate evidence to support scalable, WHO-recommended test-triage-treat approaches in low-resource settings