Exploring Biomarkers of the Carcinogenesis of Intraductal... | NCT05433935

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

NCT05433935

Sponsor

Zhejiang University

Status

Recruiting

Last Update Posted

Jan 27, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Intraductal Papillary Mucinous Neoplasm

Interventions

Observation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jun 30, 2032Estimated

Completion Date

Dec 31, 2033Estimated

First Submitted Date

Jun 22, 2022

First Submission Date that Met QC Criteria

Jun 22, 2022

First Posted Date

Jun 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2023

Last Update Posted Date

Jan 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

TingBo Liang, The chairman of the First Affiliated Hospital of Zhejiang, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Zhejiang UniversityOTHER

Collaborators

Name	Class
The Second Hospital of Hebei Medical University	OTHER
Second Affiliated Hospital of Nanchang University	OTHER
Meng Chao Hepatobiliary Hospital of Fujian Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective IPMN cohort		Multi-omics analysis of 5000 prospectively collected samples.	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	This is an observational study.	Prospective IPMN cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The accuracy of IPMN malignant transformation		Up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
the probability of IPMN malignant transformation		Up to 10 years
rates of surgical resection		Up to 10 years
survival after surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tingbo Liang, PhD	Contact	+86 19941463683		liangtingbo@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Tingbo Liang, PhD	Zhejiang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.