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Recruiting NCT05433935

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

Observational Intraductal Papillary Mucinous Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation.
Who it may be relevant to
Registry conditions: Intraductal Papillary Mucinous Neoplasm. Basic parameters: 0 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed 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.

Interventions

  • Other Observation
    This is an observational study.

Primary outcome measures

  • The accuracy of IPMN malignant transformation [Time frame: Up to 10 years]
Secondary outcome measures (3)
  • the probability of IPMN malignant transformation [Time frame: Up to 10 years]
  • rates of surgical resection [Time frame: Up to 10 years]
  • survival after surgery [Time frame: Up to 10-15 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • the First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT05433935 · PCIPMN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗