NCT05848154

Application of ctDNA in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer

A Single-center, Observational, Prospective Cohort Study of ctDNA Testing in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 92 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.

Detailed description

Pancreatic cancer is highly malignant with poor prognosis, and the overall 5-year survival rate is only about 9%. The value of neoadjuvant therapy in pancreatic cancer has been demonstrated by many studies, and a scientific and accurate evaluation of the efficacy of neoadjuvant therapy is crucial to its implementation and achieving the best outcomes. Circulating tumor DNA (ctDNA) analysis provides a non-invasive way to repeatedly assess the genomic profile of tumor. With improvements in detection techniques providing higher levels of sensitivity, ctDNA analysis is rapidly being accepted as a reliable tool in oncology. The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.

Conditions

• Patients With Non-metastatic Pancreatic Cancer
• Evaluation of Tumor Resectability Shall be Made in Consensus at Multidisciplinary Meetings, According to NCCN Guideline Version 1.2022 Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ctDNA detection	Blood samples are collected from patients at different time points during the monitoring process before treatment, after treatment, after surgery, and after adjuvant therapy/chemotherapy. ctDNA detection is performed on blood samples of all enrolled patients. WES and RNA-seq of samples from patients before and after treatment are performed to reveal the mechanisms of drug resistance.

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2023-05-08
• Last updated: 2023-05-16

Locations

1 site across 1 country: China