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Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes

RecruitingPhase 2Ages 18 Years - anyAllInstituto do Cancer do Estado de São Paulo
NCT06640283 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

After definitive radiotherapy (RT) treatment (with or without chemotherapy), cervical and anal canal neoplasms frequently exhibit disease persistence or recurrence. Due to the local inflammatory process post-treatment, response assessment by imaging (current gold standard) is limited, often necessitating multiple follow-ups and repeated invasive biopsies. Conventional follow-up is complex and costly, requiring equipment from secondary and tertiary services, trained radiologists, and patient exposure to radiation and contrast. In this context of human papillomavirus(HPV)-related neoplasms, recent studies have demonstrated the role of ctDNA (circulating tumor DNA) in assessing the risk of recurrence or disease progression, providing a rationale for using the tool in two fronts: * Optimizing follow-up based on serial monitoring of ctDNA; * Selecting patients with positive ctDNA after RT,

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📋 Eligibility rules (as published)
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.
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What it tests

  • ctDNA test
  • Pembrolizumab
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Where

1 site
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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