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CompletedNCT02810730PAPAFAUpdated Jan 13, 2020

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

An interventional study of Pancreatic MRI in Prevalence of Pancreas Adenocarcinomas, sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon. Completed at 9 sites in France. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jun 2015, registered May 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
40 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Prevalence of Pancreas Adenocarcinomas

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Keywords

  • pancreas
  • adenocarcinoma
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.

This study's enrollment of 200 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon is the lead sponsor of 20 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Other
    Single arm

    Pancreatic MRI in the 6 months following the first consultation

    Procedure: Pancreatic MRI

Interventions

  • ProcedurePancreatic MRI

    Pancreatic MRI in the 6 months following the first consultation

06

What researchers measure

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.

    Time frame: six months after the last inclusion

Secondary outcomes

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

    Time frame: six months after the last inclusion

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

    Time frame: six months after the last inclusion

  3. Height of the lesions

    Time frame: six months after the last inclusion

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

    Time frame: six months after the last inclusion

  5. Localisation of the lesions

    Time frame: six months after the last inclusion

  6. Number of lesions

    Time frame: six months after the last inclusion

  7. Aspect of the lesion (solid and/or liquid)

    Time frame: six months after the last inclusion

07

Study locations

9 sites
  • Clinique Convert
    Bourg-en-Bresse, France
  • Infirmerie Protestante
    Caluire et Cuire, 69300, France
  • Clinique du Val d'Ouest
    Ecully, 69130, France
  • Groupe Hospitalier Mutualiste des Eaux Claires
    Grenoble, 38028, France
  • Centre des maladies du foie et de l'appareil digestif
    Irigny, France
  • Centre Hospitalier Saint Joseph Saint Luc
    Lyon, 69007, France
  • Hôpital privé Jean Mermoz
    Lyon, 69008, France
  • Hôpital de Villefranche
    Villefranche sur Saône, 69655, France
  • Clinique des Portes du Sud
    Vénissieux, 69694, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02810730
Lead sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Responsible party
Sponsor
First posted
Jun 23, 2016
Start date
Jun 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 13, 2020

Study contacts

Anne-marie Marion Audibert
study director

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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