The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer

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.

Sex

Female

Minimum age

18 Years

Maximum age

80 Years

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

• BACKGROUNDTian X, Ge D, Zhang F, Zhang B, Bai W, Xu X, Li Z, Cao Y, Li P, Zou K, Zou L. Dynamic analysis of circulating tumor DNA to predict prognosis and monitor therapeutic response in metastatic relapsed cervical cancer. Int J Cancer. 2021 Feb 15;148(4):921-931. doi: 10.1002/ijc.33362. Epub 2020 Nov 7. PMID 33113150
• BACKGROUNDTian J, Geng Y, Lv D, Li P, Cordova M, Liao Y, Tian X, Zhang X, Zhang Q, Zou K, Zhang Y, Zhang X, Li Y, Zhang J, Ma Z, Shao Y, Song L, Owen GI, Li T, Liu R, Liu Q, Zou L, Zhang Z, Li Z. Using plasma cell-free DNA to monitor the chemoradiotherapy course of cervical cancer. Int J Cancer. 2019 Nov 1;145(9):2547-2557. doi: 10.1002/ijc.32295. Epub 2019 Apr 16. PMID 30919951
• BACKGROUNDPan Y, Zhang JT, Gao X, Chen ZY, Yan B, Tan PX, Yang XR, Gao W, Gong Y, Tian Z, Liu SM, Lin H, Sun H, Huang J, Liu SY, Yan HH, Dong S, Xu CR, Chen HJ, Wang Z, Li P, Guan Y, Wang BC, Yang JJ, Tu HY, Yang XN, Zhong WZ, Xia X, Yi X, Zhou Q, Wu YL. Dynamic circulating tumor DNA during chemoradiotherapy predicts clinical outcomes for locally advanced non-small cell lung cancer patients. Cancer Cell. 2023 Oct 9;41(10):1763-1773.e4. doi: 10.1016/j.ccell.2023.09.007. PMID 37816331
• BACKGROUNDZhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486. PMID 35543554
• BACKGROUNDLiu T, Yao Q, Jin H. Plasma Circulating Tumor DNA Sequencing Predicts Minimal Residual Disease in Resectable Esophageal Squamous Cell Carcinoma. Front Oncol. 2021 May 20;11:616209. doi: 10.3389/fonc.2021.616209. eCollection 2021. PMID 34094900
• BACKGROUNDSchwarzenbach H, Hoon DS, Pantel K. Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer. 2011 Jun;11(6):426-37. doi: 10.1038/nrc3066. Epub 2011 May 12.