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

Ovarian Cancer Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Surgical treatment cohort (N=40):

Collect surgical tumor tissue samples from the screening stage of patients in this cohort, as well as peripheral blood samples (20 ml/time) from baseline, postoperative, postoperative radiotherapy and chemotherapy, consolidation therapy (if any), and a 2-year follow up with 6 months/time . (A total of one tissue sample, 7-8 peripheral blood samples )

Radical radiotherapy and chemotherapy treatment cohort (N=40):

Radical radiotherapy and chemotherapy cohort: Collect baseline tumor tissue samples from patients during the screening stage, as well as peripheral blood samples (20 ml/time) from baseline, mid-term of radical radiotherapy and chemotherapy, after radical radiotherapy and chemotherapy, after consolidation treatment (if any), and a 2-year follow-up stage of 6 months/time. (A total of one tissue sample, 7-8 peripheral blood samples )

If you voluntarily participate in this study, we will require your cooperation in completing the following tasks: the entire research process consists of a screening period and a follow-up period, and it will take approximately 5 years for you to complete the entire research period. If you are willing to participate in this study, we will obtain your surgical tissue samples and obtain peripheral blood samples (20 ml/time) from a total of 7-8 times during your 5-year follow-up. The MRD detection results of each timepoint throughout the entire trial process will be promptly fed back to you and your clinical doctors for your clinical treatment plan decision-making. Before formulating your clinical treatment plan, the clinical doctor will provide you with detailed information, discussion, and confirmation. Only after receiving your confirmation can you proceed with the implementation. Throughout the entire research process, we will promptly provide you with any information such as detection indicators that may affect your decision-making. You also have the right to withdraw from this study at any time without retaliation, discrimination, or any other unfair treatment. We will protect any personal privacy information of you.

If you participate in this study, you will receive a total of 6-7 free peripheral blood based deep ctDNA-MRD tests (valued at 3800 yuan/test) throughout your entire treatment and follow-up stages. Through continuous monitoring of peripheral blood ctDNA-MRD nodes, you can advance imaging to indicate your risk of disease recurrence, detect disease progression as soon as possible, effectively improve your treatment effectiveness and clinical benefits, and evaluate your treatment efficacy as soon as possible Prognosis assessment may lead to more effective control or improvement of your personal disease treatment and quality of life. The detection results of each time will be promptly fed back to you and your research doctors to assist in your clinical decision-making and disease risk warning. Meanwhile, your participation in this study may also contribute to the improvement of solid tumor diagnosis and treatment techniques, which may bring benefits to other patients in the future. ;

Related Conditions & MeSH terms

• Ovarian Cancer

• NCT number: NCT06283875
• Study type: Observational [Patient Registry]
• Source: Geneplus-Beijing Co. Ltd.
• Contact: Jinhua Zhou
• Phone: +86 13914024750
• Email: jsjhzh@126.com
• Status: Not yet recruiting
• Start date: March 1, 2024
• Completion date: January 30, 2029