Prevalence Of Pancreatic Anomalies Of Patients With A 1st Degree Familial History Of Pancreatic Adenocarcinoma

Study Overview

Prevalence of Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is increasing both in France and in Europe, whereas all the other cancers are decreasing in Europe. Moreover, its seriousness is still high, with a mortality rate higher than the average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic anomalies which can be revealed thanks to imaging, for patients having a 1st degree pancreatic adenocarcinoma familial history. This could allow detection of lesions which are less than 10 mm long, and improve the dark prognostic of this pathology.

N/A

Prevalence of Pancreas Adenocarcinomas

PROCEDURE: Pancreatic MRI

0502198069

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-05-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-01-09
First Submitted that Met QC Criteria 2016-06-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-01-13
First Posted (ACTUAL) 2016-06-23	Results First Posted N/A	Last Verified 2020-01

Study Plan

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

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Single arm Pancreatic MRI in the 6 months following the first consultation	PROCEDURE: Pancreatic MRI Pancreatic MRI in the 6 months following the first consultation

Participant Group/Arm

Intervention/Treatment

OTHER: Single arm

Pancreatic MRI in the 6 months following the first consultation

PROCEDURE: Pancreatic MRI

Pancreatic MRI in the 6 months following the first consultation

Primary Outcome Measures	Measure Description	Time Frame
Number of patients for whom the MRI and/or the echo endoscopy has shown a parenchymatous or ductal pancreatic anomaly	For every patients who will have a pancreatic MRI detecting an anomaly, the echo endoscopy will be done. A cytology of the lesion from the echo endoscopy will be done for the solid lesions and for the indetermined cystic lesions (that is to say, the lesions which don't meet the literature set criteria for serous kyst or intraductal papillary and mucinous tumor of the pancreas) ; which is usually done in health care.	six months after the last inclusion

Secondary Outcome Measures	Measure Description	Time Frame
Number of patients for whom the MRI has brought to light a parenchymatous and/or ductal pancreatic anomaly		six months after the last inclusion
Number of patients for whom the echo endoscopy has brought to light a parenchymatous and/or ductal pancreatic anomaly		six months after the last inclusion
Height of the lesions		six months after the last inclusion
Correlation between the data from the MRI and those from the echo endoscopy		six months after the last inclusion
Localisation of the lesions		six months after the last inclusion
Number of lesions		six months after the last inclusion
Aspect of the lesion (solid and/or liquid)		six months after the last inclusion

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
40 Years

Accepts Healthy Volunteers:
1

patients with a 1st degree familial history of pancreas adenocarcinoma
patients older than 40
patients whose life expectancy is > 3 months
inform and consent form signed
patient insured under the French social security system

contraindication to the MRI (pace-maker, implanted metallic material, medical history of allergy to the contrast agent, end-stage renal failure, pregnancy, claustrophobia)
contraindication to anesthesia to do the echo endoscopy
1st degree family history of 2 pancreas adenocarinomas
medical history of allergy to benzylic alcool
contraindication to dimeglumine gadobenate
pregnant or breastfeeding woman, according to the questioning
subjets who don't have the legal capacity to consent

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Anne-marie Marion Audibert,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record