Blood ctDNA testing to guide follow-up and treatment for HPV-related cervical and anal canal cancers.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Finding HPV DNA in the blood of people with anal or cervical cancer.

  This study will test whether a blood test can find HPV DNA in people with HPV-related anal or cervical cancer before, during, and after radiation treatment.

  Recruiting at 2 sites University of Chicago · Chicago, Illinois and 1 other locations · NCT04857528

• Immunotherapy using E7 TCR-T cells for HPV-related cancers

  This study is testing a new immunotherapy using E7 TCR-T cells to see if it can help people with advanced HPV-related cancers like cervical and throat cancer feel better and improve their health.

  Recruiting at 3 sites Phase 2 Rutgers, The State University of New Jersey · Bethesda, Maryland and 2 other locations · NCT05686226

• E7 T-cell therapy for advanced HPV-related cancers

  This study is testing a new treatment using specially modified immune cells to see if it can help people with advanced cancers linked to HPV feel better and live longer.

  Recruiting at 2 sites Phase 1/2 Rutgers, The State University of New Jersey · New Brunswick, New Jersey and 1 other locations · NCT05639972

• HPV DNA-guided chemoradiation with Retifanlimab for locally advanced anal cancer

  This study tests whether adjusting chemoradiation doses based on HPV ctDNA results and adding Retifanlimab after CRT can improve outcomes for adults with new, locally advanced anal cancer.

  Recruiting Phase 2 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07425054

• 15-valent HPV vaccine for people aged 9–45 in China.

  This trial will test whether a 15‑valent HPV vaccine is safe and prompts immune responses in people aged 9–45.

  Recruiting Phase 2 Shanghai Bovax Biotechnology Co., Ltd. · Nanning, Guangxi · NCT06756269

• Screening methods for high-risk anal cancer patients

  This study is testing new ways to screen for early signs of anal cancer in high-risk people, especially those living with HIV, to help improve their health outcomes.

  Recruiting at 4 sites Emory University · Miami, Florida and 3 other locations · NCT06628570

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.