Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN) (IPMN)

May 20, 2021 updated by: Jean-Baptiste CHEVAUX, Central Hospital, Nancy, France

Sensitivity and Specificity Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)

Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis.

IPMNs require characterization to clarify their potential for degeneration. Clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery.

Pancreatic surgery remains invasive with high morbidity and mortality rates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a monoservice and monocentric retrospective study at the Nancy CHRU. We will study the risk factors for IPMNs degeneration in order to determine the most sensitive and specific.

To do this, we will use high-grade dysplasia or invasive cancer on the histological analysis of surgical specimens as the primary endpoint.

The study population will be patients with Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021.

Study Type

Observational

Enrollment (Anticipated)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nancy, France, 54000
        • Recruiting
        • Jean-Baptiste CHEVAUX
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean Baptiste JC CHEVAUX
        • Sub-Investigator:
          • Remy RF FONTANIE
        • Sub-Investigator:
          • Marion MS SCHAEFER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021

Description

Inclusion Criteria:

  • Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021, adults and without legal protection measures

Exclusion Criteria:

  • IPMNs not operated
  • Pancreatic cancer without IPMNs
  • Patients whose state of health contraindicates pancreatic surgery
  • Non-adult patient
  • Patients under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High-grade dysplasia or invasive cancer
Time Frame: 12 years
High-grade dysplasia or invasive cancer on histological analysis of the surgical specimen
12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Jean Baptiste JC CHEVAUX, Centre Hospitalier Régional Universitaire de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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