Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

NCT ID: NCT05188716

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-10

Study Completion Date

2022-01-15

Brief Summary

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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

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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.

Conditions

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Cervical Cancer Benign Tumor of Uterus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chuangzhen Chen

OTHER

Sponsor Role lead

Responsible Party

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Chuangzhen Chen

Deputy Director, Department of Radiation Oncology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chuangzhen Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Cancer Hospital of Shantou University Medical College

Locations

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Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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Immune002

Identifier Type: -

Identifier Source: org_study_id

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