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

Prevalence, With Medical Imaging, of the Parenchymatous and/or Ductal 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.

Study Overview

• Status: Completed
• Conditions: Prevalence of Pancreas Adenocarcinomas
• Intervention / Treatment: Procedure: Pancreatic MRI

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bourg-en-Bresse, France
    • Clinique Convert
  • Caluire et Cuire, France, 69300
    • Infirmerie Protestante
  • Ecully, France, 69130
    • Clinique du Val d'Ouest
  • Grenoble, France, 38028
    • Groupe Hospitalier Mutualiste des Eaux Claires
  • Irigny, France
    • Centre des maladies du foie et de l'appareil digestif
  • Lyon, France, 69008
    • Hopital privé Jean Mermoz
  • Lyon, France, 69007
    • Centre Hospitalier Saint Joseph Saint Luc
  • Villefranche sur Saône, France, 69655
    • Hôpital de Villefranche
  • Vénissieux, France, 69694
    • Clinique des Portes du Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Investigators: Study Director: Anne-marie Marion Audibert

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pancreas; adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 0502198069