Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Investigating Mechanisms That Dictates Tumor Immunogenicity and Exploring Biomarkers That Could Help Predict the Anti-tumor Immune Response in Patients With Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188716
• Other study ID #: Immune002
• Status: Completed
• Start date: December 10, 2020
• Est. completion date: January 15, 2022

Study information

• Verified date: February 2024
• Source: Shantou University Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 15, 2022
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chuangzhen Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression status of biomarkers during treatment and follow-up	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.	From the date of enrollment until the date of disease progression, assessed up to 5 years