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

NCT06283875NOT_YET_RECRUITINGOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Geneplus-Beijing Co. Ltd.

Enrollment

80

Start Date

2024-12-01

Completion Date

2026-01-30

Study Type

OBSERVATIONAL

Official Title

A Prospective, Single Center Clinical Study on the Clinical Significance of Personalized ctDNA-MRD in Predicting the Efficacy and Monitoring the Risk of Recurrence of Cervical Cancer

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

DFS of enrolled patients for 2 years

DFS of enrolled patients for 2 years

Time frame: 2 years

Locations

The First Affiliated Hospital of Soochow University, Suzhou, China

Linked Papers

2020-11-07

Dynamic analysis of circulating tumor DNA to predict prognosis and monitor therapeutic response in metastatic relapsed cervical cancer

AbstractLimited and inefficient treatment options exist for metastatic relapsed cervical cancer (MRCC), and there are currently no reliable indicators to guide therapeutic selection. We performed deep sequencing analyses targeting 322 cancer‐related genes in plasma cell‐free DNA and matched white blood cells in 173 serial blood samples from 82 locally advanced CC (LACC) or MRCC patients and when possible during treatment. We identified five notable nonsynonymous mutant genes (PIK3CA, BRAF, GNA11, FBXW7 and CDH1) in the MRCC samples as the metastatic relapse significantly mutated (MSG) genes and found that MRCC patients with any detectable MSG mutations had significantly shorter progression‐free survival (PFS) (P = .005) and overall survival (OS) (P = .007) times than those without detectable MSG mutations. Additionally, analyses of matched prechemotherapy and postchemotherapy plasma revealed that a reduction in the number of MSG mutations after chemotherapy was significantly associated with partial remission (PR) and stable disease (SD) (P = .007). Among the patients included in the longitudinal tracking ctDNA analysis, an increase in MSG mutations was observed earlier in response to disease progression than radiological imaging. Our results outline the mutation profiles of MRCC. We show how longitudinal monitoring with ctDNA in liquid biopsy samples provides both predictive and prognostic information during treatment.

Linked Investigators