Clincosm LogoSign in Get a demo

Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

Sponsor
Chuangzhen Chen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05188716
Collaborator
(none)
100
Enrollment
1
Location
59.7
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Dec 10, 2020
    Anticipated Primary Completion Date :
    Feb 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital of Shantou University Medical College Shantou Guangdong China 515031

    Sponsors and Collaborators

    • Chuangzhen Chen

    Investigators

    • Principal Investigator: Chuangzhen Chen, MD, Affiliated Cancer Hospital of Shantou University Medical College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chuangzhen Chen, Deputy Director, Department of Radiation Oncology, Shantou University Medical College
    ClinicalTrials.gov Identifier:
    NCT05188716
    Other Study ID Numbers:
    • Immune002
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chuangzhen Chen, Deputy Director, Department of Radiation Oncology, Shantou University Medical College
    Cervical cancer
    Tumor immunogenicity
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of Jan 12, 2022