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

Primary Purpose

Prevalence of Pancreas Adenocarcinomas

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Pancreatic MRI

About this trial

This is an interventional diagnostic trial for Prevalence of Pancreas Adenocarcinomas focused on measuring pancreas, adenocarcinoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Pancreatic MRI in the 6 months following the first consultation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients for whom the MRI has brought to light a parenchymatous and/or ductal pancreatic anomaly

Number of patients for whom the echo endoscopy has brought to light a parenchymatous and/or ductal pancreatic anomaly

Height of the lesions

Correlation between the data from the MRI and those from the echo endoscopy

Localisation of the lesions

Number of lesions

Aspect of the lesion (solid and/or liquid)

Full Information

NCT ID

NCT02810730

First Posted

May 6, 2016

Last Updated

January 9, 2020

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT02810730

Brief Title

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

Acronym

PAPAFA

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prevalence of Pancreas Adenocarcinomas

Keywords

pancreas, adenocarcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Other

Arm Description

Pancreatic MRI in the 6 months following the first consultation

Intervention Type

Procedure

Intervention Name(s)

Pancreatic MRI

Intervention Description

Pancreatic MRI in the 6 months following the first consultation

Primary Outcome Measure Information:

Title

Number of patients for whom the MRI and/or the echo endoscopy has shown a parenchymatous or ductal pancreatic anomaly

Description

Time Frame