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

NCT ID: NCT02810730

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prevalence of Pancreas Adenocarcinomas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm

Pancreatic MRI in the 6 months following the first consultation

Group Type OTHER

Pancreatic MRI

Intervention Type PROCEDURE

Pancreatic MRI in the 6 months following the first consultation

Interventions

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Pancreatic MRI

Pancreatic MRI in the 6 months following the first consultation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Saint Joseph Saint Luc de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-marie Marion Audibert

Role: STUDY_DIRECTOR

Locations

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Clinique Convert

Bourg-en-Bresse, , France

Site Status

Infirmerie Protestante

Caluire-et-Cuire, , France

Site Status

Clinique du Val d'Ouest

Écully, , France

Site Status

Groupe Hospitalier Mutualiste des Eaux Claires

Grenoble, , France

Site Status

Centre des maladies du foie et de l'appareil digestif

Irigny, , France

Site Status

Centre Hospitalier Saint Joseph Saint Luc

Lyon, , France

Site Status

Hôpital privé Jean Mermoz

Lyon, , France

Site Status

Clinique des Portes du Sud

Vénissieux, , France

Site Status

Hôpital de Villefranche

Villefranche-sur-Saône, , France

Site Status

Countries

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France

Other Identifiers

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0502198069

Identifier Type: -

Identifier Source: org_study_id

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