Clincosm LogoSign in Get a demo

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

Sponsor
Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05433935
Collaborator
(none)
5,000
Enrollment
138
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Observation

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Open Large Cohort Study of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2032
Anticipated Study Completion Date :
Dec 31, 2033

Arms and Interventions

Arm Intervention/Treatment
Prospective IPMN cohort

Multi-omics analysis of 5000 prospectively collected samples.

Other: Observation
This is an observational study.

Outcome Measures

Primary Outcome Measures

  1. the predictive accuracy of IPMN malignant transformation [Up to 10 years]

    We will use the biomarkers and follow-up data of the patients to construct a prediction model, and the accuracy of model to predicting the probability of IPMN malignant transformation is the primary endpoint.

Secondary Outcome Measures

  1. the probability of IPMN malignant transformation [Up to 10 years]

  2. rates of surgical resection [Up to 10 years]

  3. survival after surgery [Up to 10-15 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhejiang University

Investigators

  • Study Chair: Tingbo Liang, PhD, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TingBo Liang, The chairman of the First Affiliated Hospital of Zhejiang, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05433935
Other Study ID Numbers:
  • PCIPMN
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by TingBo Liang, The chairman of the First Affiliated Hospital of Zhejiang, Zhejiang University
intraductal papillary mucinous neoplasm
biomarkers
prospective cohort
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Jun 27, 2022