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

NCT ID: NCT05433935

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2033-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Intraductal Papillary Mucinous Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective IPMN cohort

Multi-omics analysis of 5000 prospectively collected samples.

Observation

Intervention Type OTHER

This is an observational study.

Interventions

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Observation

This is an observational study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Meng Chao Hepatobiliary Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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TingBo Liang

The chairman of the First Affiliated Hospital of Zhejiang

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tingbo Liang, PhD

Role: STUDY_CHAIR

Zhejiang University

Locations

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the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tingbo Liang, PhD

Role: CONTACT

+86 19941463683

Facility Contacts

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Qi Zhang

Role: primary

13858108798

Other Identifiers

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PCIPMN

Identifier Type: -

Identifier Source: org_study_id

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