Tokyo, Dec. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060174) titled 'A study to examine immune changes after radiation treatment in patients with cervical cancer' on Dec. 23.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - National Institutes for Quantum Science and Technology

Condition: Condition - Cervical cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - This study aims to clarify the differences in immune responses induced after X-ray and carbon-ion radiotherapy in patients with cervical cancer using tumor tissues and peripheral blood samples. Spatial and functional immune changes will be integratively analyzed in relation to two-year local control and overall survival. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Tumor biopsy and peripheral blood sampling will be performed for research purposes before the initiation of radiotherapy as part of routine clinical diagnosis and during the radiation treatment period as an additional procedure outside routine diagnosis. Collected tumor tissues and blood samples will be used for immune response analyses, including spatial analysis, single-cell analysis, and TCR repertoire analysis.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - Patients with cervical cancer scheduled to receive X-ray or carbon-ion radiotherapy Patients for whom tumor biopsy can be obtained before the initiation of radiotherapy Patients for whom additional tumor biopsy and peripheral blood sampling during the radiation treatment period for research purposes are feasible Female patients aged 20 years or older Patients who have provided written informed consent to participate in this study Key exclusion criteria - Patients with severe immunosuppressive conditions Patients who are pregnant or possibly pregnant Patients judged by the treating physician to be inappropriate for participation in this study Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 26 Day Anticipated trial start date - 2026 Year 01 Month 15 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068821

Disclaimer: Curated by HT Syndication.