Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

Completed

• Conditions: Cervical Cancer; Benign Tumor of Uterus

• Registration Number: NCT05188716
• Lead Sponsor: Chuangzhen Chen

Brief Summary

This study aims to investigate mechanisms that dictate tumor immunogenicity and to explore potential biomarkers that could help predict changes of tumor immunogenicity and therapeutic response in patients with cervical cancer after chemoradiotherapy or surgery.

Detailed Description

Patients pathologically confirmed with cervical cancer or benign gynecologic tumor that requires chemoradiotherapy or surgery will be recruited to this study. Tumor samples, normal epithelium of the cervix or other biological samples will be obtained from patients who will receive surgery to establish the baseline status of tumor/mucosal immunogeneicity. For patients undergoing definite radiotherapy, tumor biopsies, collection of blood samples and microbiota will be performed before and during the course of treatment and when the disease progressed. These biological specimens will be used to investigate signaling pathways that determine tumor immungenenicity and their dynamic changes during treatment and to explore feasible biomarkers that could reflect and help monitor the inter- and intra-patient varariation of tumor immunogenicity.

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2021-05-20
• Primary Completion: 2021-10-13
• Study First Submitted QC: 2021-12-27
• Study First Posted: 2022-01-12
• Study Completion: 2022-01-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Pathological proven diagnosis of cervical cancer or benign gynecologic tumor and will undergoing panhysterectomy or pathological proven diagnosis of cervical cancer and will undergoing radiotherapy
• Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery
• Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria

• History of autoimmune diseases
• History of immunotherapy
• History of pelvic radiotherapy
• Will receive immunotherapy during the course of treatment
• Contraindications for biopsy, such as high bleeding risk

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression status of biomarkers during treatment and follow-up	From the date of enrollment until the date of disease progression, assessed up to 5 years	Expression status of biomarkers in patients' biological specimens through the course of treatment and during follow-up as assessed by a variety of means, including RNA-seq, DNA-seq, RT-qPCR, IHC, WB, flow cytometry and ELISA.

Trial Locations

Locations (1)

Cancer Hospital of Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China