NCT06283875Not yet recruiting
The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer
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
Source: ClinicalTrials.gov · Last updated 18 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 30 Jan 2026
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Diseases
- Cervical cancer, Ovarian cancer
- NCT number
- NCT06283875
What you commit to
- Study type: Observational
- Planned participants: 80
- From 1 Dec 2024 to the primary completion date, 30 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- (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.
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.