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

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ClinicalTrials.gov Identifier: NCT02810730
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Saint Joseph Saint Luc de Lyon

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.

Condition or disease Intervention/treatment Phase
Prevalence of Pancreas Adenocarcinomas Procedure: Pancreatic MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of patients for whom the MRI and/or the echo endoscopy has shown a parenchymatous or ductal pancreatic anomaly [ Time Frame: six months after the last inclusion ]
    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 :
  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 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810730


Locations
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France
Clinique Convert
Bourg-en-Bresse, France
Infirmerie Protestante
Caluire et Cuire, France, 69300
Clinique du Val d'Ouest
Ecully, France, 69130
Groupe Hospitalier Mutualiste des Eaux Claires
Grenoble, France, 38028
Centre des maladies du foie et de l'appareil digestif
Irigny, France
Centre Hospitalier Saint Joseph Saint Luc
Lyon, France, 69007
Hôpital privé Jean Mermoz
Lyon, France, 69008
Hôpital de Villefranche
Villefranche sur Saône, France, 69655
Clinique des Portes du Sud
Vénissieux, France, 69694
Sponsors and Collaborators
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Investigators
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Study Director: Anne-marie Marion Audibert
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Responsible Party: Centre Hospitalier Saint Joseph Saint Luc de Lyon
ClinicalTrials.gov Identifier: NCT02810730    
Other Study ID Numbers: 0502198069
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Keywords provided by Centre Hospitalier Saint Joseph Saint Luc de Lyon:
pancreas
adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms