NCT02810730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

May 6, 2016

Last Update Submit

January 9, 2020

Conditions

Prevalence of Pancreas Adenocarcinomas

Keywords

pancreasadenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Single arm

OTHER

Pancreatic MRI in the 6 months following the first consultation

Procedure: Pancreatic MRI

Interventions

Pancreatic MRIPROCEDURE

Pancreatic MRI in the 6 months following the first consultation

Single arm

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • st 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Clinique Convert

Bourg-en-Bresse, France

Location

Infirmerie Protestante

Caluire-et-Cuire, 69300, France

Location

Clinique du Val d'Ouest

Écully, 69130, France

Location

Groupe Hospitalier Mutualiste des Eaux Claires

Grenoble, 38028, France

Location

Centre des maladies du foie et de l'appareil digestif

Irigny, France

Location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

Location

Hôpital privé Jean Mermoz

Lyon, 69008, France

Location

Clinique des Portes du Sud

Vénissieux, 69694, France

Location

Hôpital de Villefranche

Villefranche-sur-Saône, 69655, France

Location

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Anne-marie Marion Audibert

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

June 23, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

FR(9)