Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Explorations of Cell-free DNA Multi-omics Technology in Detection of Minimal Residual Disease and Disease Prognosis After Surgery in Early Pancreatic Ductal Adenocarcinoma: A Single-center, Prospective, Observational Case Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06151691
• Other study ID #: PC-MRD
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Fudan University
• Contact: Xian-Jun Yu, M.D., Ph.D.
• Phone: +86 21 64175590
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: November 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion criteria:

1. Patients with clinically and/or pathologically diagnosis of stage I/II pancreatic ductal adenocarcinoma;

2. Aged = 40 years and < 75 years, both sexes;

3. Patients receive radical resection with curative intent, followed by adjuvant therapy;

4. Tumour size not less than 1 cm * 1 cm * 1 cm and be able to provide surgical tissue samples for molecular testing after pathological evaluation;

5. Eastern Cooperative Oncology Group (ECOG) score of 0-2;

6. Negative margins (R0 or R1) by naked eye or no recurrence/metastasis detected on imaging after surgery or before adjuvant therapy, and CA 19-9<37 U/ml;

7. Patients understand and voluntarily sign the informed consent form and follow the sampling, assessment and visit requirements of this study.

Exclusion criteria:

1. Pregnant and lactating (by self-report);

2. Any tumor history of malignancies;

3. Positive cutting margins (R2);

4. Received neoadjuvant therapy before surgery;

5. Not be able to receive radical surgery;

6. Organ transplantation history;

7. Organ dysfunction (moderate or severe renal impairment with absolute centrocyte count < 1.0 x 10^9/L, platelet count < 75 x 10^9/L, haemoglobin < 80 g/L, AST/ALT > 2.5 times upper limit of normal);

8. Other conditions deemed unsuitable for enrollment by the investigator.

Related Conditions & MeSH terms

• Adenocarcinoma
• Neoplasm, Residual
• Pancreatic Ductal Adenocarcinoma

Intervention

Other:
• Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test
Blood samples of participants meet the inclusion/exclusion criteria will be collected. Pancreatic ductal adenocarcinoma minimal residual disease detection test.

Locations

Country	Name	City	State
China	Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Shanghai Weihe Medical Laboratory Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.5-year disease-free survival	1.5-year disease-free survival of patients with pancreatic ductal adenocarcinoma receiving post-operative adjuvant chemotherapy.	18 months
Secondary	Sensitivity of the multi-omics prognostic model	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	18 months
Secondary	Specificity of the multi-omics prognostic model	Specificity of the multi-omics prognostic model for pancreatic ductal adenocarcinoma patients without recurrence at 95% confidence intervals.	18 months
Secondary	Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model	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.	18 months
Secondary	Sensitivity of the multi-omics prognostic model in different subgroups	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.	18 months