Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

NCT05188716 | Completed

• 1 other identifier: Immune002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Benign Tumor of Uterus

Keywords

Cervical cancer; Tumor immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients proven diagnosis of cervical cancer or benign gynecologic tumor and will have radiotherapy as part of their therapeutic regimens or will undergo surgery in Cancer Hospital of Shantou University Medical College.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuangzhen Chen: lead

Study Sites (1)

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515031, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples or the epithelium of cervix or other biological samples will be obtained from patients receiving surgery. For patients who will be treated with definite chemoradiotherapy, tumor samples, blood samples and microbiota will be collected before and during the course of treatment, and when the disease progressed.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Chuangzhen Chen, MD

  Affiliated Cancer Hospital of Shantou University Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: January 12, 2022
• Study Start: December 10, 2020
• Primary Completion: October 13, 2021
• Study Completion: January 15, 2022
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

CN (1)