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NCT Number: NCT05433935

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.

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Key information

Conditions

Intraductal Papillary Mucinous Neoplasm

Age range

0 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Qi Zhang

CONTACT

13858108798

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

This is an observational study.

Primary outcomes

  1. The accuracy of IPMN malignant transformation

    Time frame: Up to 10 years

Secondary outcomes

  1. the probability of IPMN malignant transformation

    Time frame: Up to 10 years

  2. rates of surgical resection

    Time frame: Up to 10 years

  3. survival after surgery

    Time frame: Up to 10-15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Tingbo Liang, PhD

CONTACT

[email protected]

+86 19941463683

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2032
Study completion
2033
First posted
Jun 27, 2022
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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