Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas

Intraductal Papillary Mucinous Neoplasm Clinical Trial

Official title:

A Prospective, Open Large Cohort Study of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433935
• Other study ID #: PCIPMN
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2033

Study information

• Verified date: January 2023
• Source: Zhejiang University
• Contact: Tingbo Liang, PhD
• Phone: +86 19941463683
• Email: liangtingbo[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN.

Description:

This prospective study was designed to explore biomarkers for detecting early carcinogenesis of IPMN. This study intends to prospectively and continuously enroll IPMN patients, and regularly collect biological samples including blood, urine, feces and saliva. We aimed to detect biomarkers which can predict the carcinogenesis of IPMN by multi-omics. The primary endpoint is the predictive accuracy of biomarkers for IPMN malignant transformation. The probability of IPMN malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2033
• Est. primary completion date: June 30, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 90 Years

Eligibility

Inclusion Criteria:

• clinically diagnosed as IPMN;
• without other malignant tumor;
• agree to sign informed consent.

Exclusion Criteria:

• with mental disorders which can affect cognition and cooperation;
• with serious blood diseases or taking drugs that can affect peripheral blood

Related Conditions & MeSH terms

• Intraductal Papillary Mucinous Neoplasm
• Neoplasms

Intervention

Other:
• Observation
This is an observational study.

Locations

Country	Name	City	State
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Zhejiang University	Huizhou Municipal Central Hospital, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Second Affiliated Hospital of Nanchang University, Shengzhou People's Hospital, The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of IPMN malignant transformation		Up to 10 years
Secondary	the probability of IPMN malignant transformation		Up to 10 years
Secondary	rates of surgical resection		Up to 10 years
Secondary	survival after surgery		Up to 10-15 years