The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer
Status: Not yet recruiting

This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  (1) Confirmed by histopathology and classified as stage IB-IVA cervical cancer patients according to the 2018 FIGO staging criteria;  (2) Patients can receive surgical treatment or curative radiotherapy and chemotherapy;  (3) Age range from 18 to 80 years old;  (4) General condition: ECOG 0-2;  (5) At least one measurable lesion (RECIST 1.1 standard);  (6) Be able to understand the research plan and voluntarily participate in this study, and sign an informed consent form;  (7) Good compliance, able to cooperate in collecting specimens from various nodes and provide corresponding clinical information;  (8) Having comprehensive clinical data on imaging and pathology;  (9) The estimated survival time of the patient is greater than 3 months;  (10) Having sufficient organ and bone marrow functions.  Exclusion Criteria:  1) Within 5 years, suffering from other malignant tumors or metastatic or recurrent cervical cancer;  (2) Has received any tumor treatment plan in the past;  (3) Surgical resection or curative radiotherapy and chemotherapy are not acceptable;  (4) Unable to follow the determined clinical follow-up period in conjunction with the study for follow-up;  (5) Inability to accept or provide specified efficacy evaluation methods such as CT;  (6) Suffering from autoimmune diseases;  (7) Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;  (8) Subjects with any severe and/or uncontrolled diseases;  (9) According to the researchers judgment, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study by the subjects - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study focuses on newly diagnosed cervical cancer patients who have been confirmed by histology or cytology to undergo surgical resection or curative radiotherapy and chemotherapy in locally advanced stages (stages IB-IV). A total of 80 patients who meet the inclusion criteria and voluntarily sign informed consent forms are planned to be enrolled. According to the curative treatment measures that patients can accept, the enrolled patients are divided into a operable treatment queue (N=40) and a curative radiotherapy and chemotherapy treatment queue (N=40). - SamplingMethod: Non-Probability Sample