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Completed

NCT Number: NCT05188716

Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Expression status of biomarkers during treatment and follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chuangzhen Chen

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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