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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)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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, who are at high risk of recurrence, for treatment intensification. Monitoring with ctDNA as a standalone follow-up tool in cases evolving with negative ctDNA after RT has the potential to replace imaging exams, being a minimally invasive test performed on a peripheral blood sample. Currently, ctDNA testing has expensive methodologies not available in the Unified Health System (SUS). This project aims to develop a methodology for ctDNA evaluation focused on HPV ctDNA research that is low-cost and executable in SUS, as well to assess the accuracy of this test in the population with HPV-related tumors. Additionally, we will evaluate whether the early introduction of immunotherapy in patients with positive ctDNA after definitive treatment can increase cure rates. Immunotherapy already has a well-defined role in the treatment of metastatic HPV-related neoplasms. Recently, the use of anti-programmed death-1 (anti-PD1) has also shown benefits in patients with locally advanced cervical cancer with a high risk of recurrence who are candidates for chemoradiotherapy (CRT). Therefore, its use focused on HPV-related tumors, as well as a better understanding of which patients benefit from this strategy, warrants further investigation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histological diagnosis of anal canal or cervical cancer.

• Documented presence of HPV.

• Locally confined or locally advanced disease, defined as:

‣ Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition;

⁃ Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition.

• Indication for definitive treatment with radiotherapy, with or without concomitant chemotherapy.

• Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 - 1.

• Age ≥ 18 years.

• Signing of the Informed Consent Form (ICF).

• HIV-positive patients may be included if Cluster of Differentiation 4(CD4) count is greater than or equal to 200.

• Patients may participate in other concurrent studies, as long as they do not involve interventions related to the treatment of the underlying cancer.

Locations
Other Locations
Brazil
Instituto do Câncer do Estado de São Paulo - ICESP
RECRUITING
São Paulo
Contact Information
Primary
Research Center, Assistant
icesp.pesqclinica@hc.fm.usp.br
+55 11 3893-3566
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2027-01
Participants
Target number of participants: 150
Treatments
Other: Active laboratory monitoring
Phase I Monitoring through collection of laboratory tests
Experimental: Intervention with Immunotherapy
Phase II for participants who are ctDNA positive after standard treatment.~Intervention will be with Pembrolizumab
Related Therapeutic Areas
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

This content was sourced from clinicaltrials.gov