Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- Other: Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test
- Registration Number
- NCT06151691
- Lead Sponsor
- Fudan University
- Brief Summary
This trial aims to develop a minimal residual disease (MRD) detection model for predicting recurrence of patients with stage I-II pancreatic ductal adenocarcinoma after surgery and adjuvant therapy, based on cfDNA fragmentation and methylation signal.
- Detailed Description
The entire study is divided into two stages. Stage one is the enrollment period. 51 subjects with pancreatic ductal adenocarcinoma in stages I-II who have not received neoadjuvant therapy and have undergone radical surgery were enrolled. Blood samples at the time point before surgical treatment (T0) were collected and fresh tissue specimens (cancerous tissue and adjacent normal tissue) were collected. Blood samples were subjected to methylation, fragment group, and CNV multi-omics testing, and tissue samples were subjected to target methylation area testing. Stage two is the follow-up period. Blood samples from the fifth week after surgery to before adjuvant therapy (T1) and blood samples from 4-8 weeks after adjuvant therapy (T2) were collected. Blood samples were subjected to methylation, fragment group, and CNV multi-omics testing with different techniques. The subjects were followed up for 1.5 years. According to progression and recurrence, the subjects were divided into progression group and non-progression group. Methylation and multi-omics prognosis models were trained and compared for their performance in residual detection and recurrence prediction.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Case-Cancer arm Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test
- Primary Outcome Measures
Name Time Method 1.5-year disease-free survival 18 months 1.5-year disease-free survival of patients with pancreatic ductal adenocarcinoma receiving post-operative adjuvant chemotherapy.
- Secondary Outcome Measures
Name Time Method Sensitivity of the multi-omics prognostic model 18 months Sensitivity of the multi-omics prognostic model for pancreatic ductal adenocarcinoma based on cfDNA methylation, fragmentation group, and CNV features in patients with recurrence at 95% confidence interval
Specificity of the multi-omics prognostic model 18 months Specificity of the multi-omics prognostic model for pancreatic ductal adenocarcinoma patients without recurrence at 95% confidence intervals.
Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model 18 months Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model for predicting patient recurrence of pancreatic ductal adenocarcinoma at 95% confidence intervals.
Sensitivity of the multi-omics prognostic model in different subgroups 18 months Sensitivity of the multi-omics prognostic model for predicting pancreatic ductal adenocarcinoma recurrence in different subgroups (age, underlying medical history, tumour differentiation, tumour diameter, etc.) at 95% confidence intervals.
Trial Locations
- Locations (1)
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
🇨🇳Shanghai, China