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

Launched by INSTITUTO DO CANCER DO ESTADO DE SÃO PAULO · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor patients with HPV-related cervical and anal cancers after they receive radiation treatment. The trial aims to use a test that looks for circulating tumor DNA (ctDNA) in the blood. This test could help determine if the cancer is likely to come back, and it may help avoid the need for expensive imaging scans and invasive biopsies. Researchers hope that by monitoring ctDNA, they can provide better follow-up care and identify patients who may need more intensive treatment if their ctDNA levels are high after treatment.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of anal canal or cervical cancer linked to HPV. They should also be in the early stages of cancer and eligible for radiation treatment. The trial will not accept patients with advanced cancer that has spread to other parts of the body or those with certain other health conditions. Participants will receive regular blood tests to check their ctDNA levels and may have the opportunity to receive immunotherapy if their ctDNA indicates a higher risk of cancer recurrence. This trial aims to develop a cost-effective way to use ctDNA testing in clinical practice, which could greatly improve the follow-up care for patients with these types of cancers.

Gender

ALL

Eligibility 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.