Clinical trial NCT02810730: Prevalence of Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma
Official title: Prevalence, With Medical Imaging, of the Parenchymatous and/or Ductal Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevalence of Pancreas Adenocarcinomas
Keywords: pancreas
adenocarcinoma
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients for whom the MRI and/or the echo endoscopy has shown a parenchymatous or ductal pancreatic anomaly
timeFrame: six months after the last inclusion
Secondary outcomes:
measure: Number of patients for whom the MRI has brought to light a parenchymatous and/or ductal pancreatic anomaly
timeFrame: six months after the last inclusion
measure: Number of patients for whom the echo endoscopy has brought to light a parenchymatous and/or ductal pancreatic anomaly
timeFrame: six months after the last inclusion
measure: Height of the lesions
timeFrame: six months after the last inclusion
measure: Correlation between the data from the MRI and those from the echo endoscopy
timeFrame: six months after the last inclusion
measure: Localisation of the lesions
timeFrame: six months after the last inclusion
measure: Number of lesions
timeFrame: six months after the last inclusion
measure: Aspect of the lesion (solid and/or liquid)
timeFrame: six months after the last inclusion
Other outcomes:
Locations:
city: Bourg-en-Bresse
country: France
facility: Clinique Convert
city: Caluire et Cuire
country: France
facility: Infirmerie Protestante
city: Ecully
country: France
facility: Clinique du Val d'Ouest
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste des Eaux Claires
city: Irigny
country: France
facility: Centre des maladies du foie et de l'appareil digestif
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Lyon
country: France
facility: Hôpital privé Jean Mermoz
city: Villefranche sur Saône
country: France
facility: Hôpital de Villefranche
city: Vénissieux
country: France
facility: Clinique des Portes du Sud
Study officials:
name: Anne-marie Marion Audibert
role: STUDY_DIRECTOR
References: