Blood ctDNA testing to guide follow-up and treatment for HPV-related cervical and anal canal cancers.
Dynamic Assessment of ctDNA in Patients With Cervical and Anal Canal Tumors to Optimize Follow-up and Clinical Outcomes in the Brazilian Unified Health System (SUS)
This study will test whether regular blood tests for HPV ctDNA can guide follow-up and whether giving pembrolizumab after radiotherapy helps people with HPV-related cervical or anal canal cancer who still have positive ctDNA.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06640283 on ClinicalTrials.gov |
What this trial studies
The study develops and validates a sensitive blood test to detect HPV ctDNA and then uses serial ctDNA monitoring during and after definitive radiotherapy (with or without chemotherapy). ctDNA results will be compared with standard imaging to see if blood monitoring can identify residual or recurrent disease earlier and reduce unnecessary biopsies and imaging. Patients with persistently positive ctDNA after radiotherapy may be offered pembrolizumab as a treatment intensification strategy. Long-term clinical outcomes and safety will be tracked to determine whether ctDNA-guided care improves recurrence detection and patient outcomes.
Who should consider this trial
Good fit: Adults (≥18 years) with HPV-positive cervical cancer stage IB2–IVA or anal canal carcinoma stage I–III, ECOG 0–1, scheduled for definitive radiotherapy with or without chemotherapy (HIV-positive allowed if CD4 ≥200) are ideal candidates.
Not a fit: Patients with clear distant metastases at diagnosis, those not eligible for definitive radiotherapy, or with poor performance status are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could detect recurrence earlier, reduce unnecessary imaging and biopsies, and improve outcomes by directing immunotherapy to patients at higher risk.
How similar studies have performed: Prior work has shown HPV ctDNA can detect residual or recurrent disease earlier than imaging, and pembrolizumab has activity in some HPV-related cancers, but using ctDNA to select post-radiotherapy immunotherapy is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histological diagnosis of anal canal or cervical cancer. 2. Documented presence of HPV. 3. Locally confined or locally advanced disease, defined as: 1. Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition; 2. Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition. 4. Indication for definitive treatment with radiotherapy, with or without concomitant chemotherapy. 5. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 - 1. 6. Age ≥ 18 years. 7. Signing of the Informed Consent Form (ICF). 8. HIV-positive patients may be included if Cluster of Differentiation 4(CD4) count is greater than or equal to 200. 9. Patients may participate in other concurrent studies, as long as they do not involve interventions related to the treatment of the underlying cancer. Exclusion Criteria: 1. Patients with unequivocal distant metastasis at diagnosis. 2. For participants with positive ctDNA after treatment, those candidates for participation in Phase II will be excluded if there is unequivocal radiological progression in the first imaging exam after the completion of radiotherapy (with or without chemotherapy) or routine indication for salvage surgery immediately after the conclusion of definitive treatment. 3. Need for recurrent blood transfusions, such as weekly frequency. 4. Another uncontrolled disease representing a life risk, as determined by medical judgment. 5. Personal history of another active invasive malignant neoplasm in the last 5 years, except for non-melanoma skin carcinomas and in situ carcinomas. 6. Pregnant individuals. 7. Active opportunistic infection or disease. 8. History of autoimmune diseases.
Where this trial is running
São Paulo
- Instituto do Câncer do Estado de São Paulo - ICESP — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Maria DP Estevez Diz, Doctor — Oncologist
- Study coordinator: Research Center, Assistant
- Email: icesp.pesqclinica@hc.fm.usp.br
- Phone: +55 11 3893-3566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.