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Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05188716
Enrollment
30
Registered
2022-01-12
Start date
2020-12-10
Completion date
2022-01-15
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Tumor of Uterus, Cervical Cancer

Keywords

Cervical cancer, Tumor immunogenicity

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.

Interventions

None listed

Sponsors

Chuangzhen Chen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Expression status of biomarkers during treatment and follow-upFrom the date of enrollment until the date of disease progression, assessed up to 5 yearsExpression 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026