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

NCT05433935 | Recruiting

• 1 other identifier: PCIPMN
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraductal Papillary Mucinous Neoplasm

Keywords

intraductal papillary mucinous neoplasm; biomarkers; prospective cohort

Outcome Measures

Primary Outcomes (1)

• The accuracy of IPMN malignant transformation

  Up to 10 years

Secondary Outcomes (3)

• 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

Study Arms (1)

Prospective IPMN cohort

Multi-omics analysis of 5000 prospectively collected samples.

Other: Observation

Interventions

Observation OTHER

This is an observational study.

Prospective IPMN cohort

Eligibility Criteria

• Age: 0 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ought to meet all inclusion and exclusion criteria. In addition, the patient of the prospective cohort should be thoroughly informed about the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent of the prospective cohort should be obtained from the patient prior to enrollment.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead
• The Second Hospital of Hebei Medical University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator
• Huizhou Municipal Central Hospital: collaborator

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The fresh blood, urine, feces and saliva of each patient will be collected during the surveillance. The samples of each patient will be collected at the following time points: 1) at diagnosis time of IPMN; 2) every 6 months during surveillance until malignant transformation. If patients receive surgical resection for targeted lesions, surgical specimens will also be collected.

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Tingbo Liang, PhD

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Tingbo Liang, PhD

CONTACT

+86 19941463683; liangtingbo@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chairman of the First Affiliated Hospital of Zhejiang

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): June 30, 2032
• Study Completion (Estimated): December 31, 2033
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)