Exploring Biomarkers Of The Carcinogenesis Of Intraductal Papillary Mucinous Neoplasm (IPMN) Of The Pancreas

Study Overview

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

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

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.

Intraductal Papillary Mucinous Neoplasm

OTHER: Observation

PCIPMN

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-06-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-01-26
First Submitted that Met QC Criteria 2022-06-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-01-27
First Posted (ACTUAL) 2022-06-27	Results First Posted N/A	Last Verified 2023-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Prospective IPMN cohort Multi-omics analysis of 5000 prospectively collected samples.	OTHER: Observation This is an observational study.

Participant Group/Arm

Intervention/Treatment

: Prospective IPMN cohort

Multi-omics analysis of 5000 prospectively collected samples.

OTHER: Observation

This is an observational study.

Primary Outcome Measures	Measure Description	Time Frame
The accuracy of IPMN malignant transformation		Up to 10 years

Secondary Outcome Measures	Measure Description	Time Frame
the probability of IPMN malignant transformation		Up to 10 years
rates of surgical resection		Up to 10 years
survival after surgery		Up to 10-15 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tingbo Liang, PhD

Phone Number: +86 19941463683

Email: liangtingbo@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
0 Years

Accepts Healthy Volunteers:
1

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

The Second Hospital of Hebei Medical University
Second Affiliated Hospital of Nanchang University
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Huizhou Municipal Central Hospital

Investigators

STUDY_CHAIR: Tingbo Liang, PhD, Zhejiang University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record