Clinical trial NCT05188716: Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Benign Tumor of Uterus
Keywords: Cervical cancer
Tumor immunogenicity
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Expression status of biomarkers during treatment and follow-up
timeFrame: From the date of enrollment until the date of disease progression, assessed up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
Study officials:
affiliation: Affiliated Cancer Hospital of Shantou University Medical College
name: Chuangzhen Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: