Blood tumor DNA tracking in people with locally advanced cervical cancer
Studies tumor DNA in blood to track cervical cancer in 80 patients.
Plain-language title generated from the registry record
Registry title: The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer
Key facts
- Where
- Suzhou, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 80 with locally advanced cervical cancer who can have surgery or radiotherapy with chemotherapy meant to remove all of the disease.
- Age
- 18 to 80 years
- Sex
- Women only
- Disease stage
- Cervical cancer stage IB-IVA (2018 FIGO staging), confirmed by tissue examination, with at least one measurable lesion.
- Earlier treatment
- People who have had any earlier tumor treatment cannot join.
- Biomarker or test result
- Tumor tissue is tested for mutations with a 1021 genes panel, and ctDNA is followed in blood samples.
Main reasons for not taking part
- Another cancer within 5 years, or metastatic or recurrent cervical cancer
- Any earlier tumor treatment
- Cannot have surgery or radiotherapy with chemotherapy
- Autoimmune disease
- Severe or uncontrolled disease, or a mental disorder or history of drug abuse who cannot quit
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06283875, who can take part
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Geneplus-Beijing Co. Ltd.
- Trial code
- NCT06283875
- Record updated
- 18 July 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: (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: 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.