Skip to main content
OpenTrials
Completed

NCT Number: NCT02810730

Prevalence of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prevalence of Pancreas Adenocarcinomas Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Convert, Bourg-en-Bresse, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreatic MRI

Procedure

Pancreatic MRI in the 6 months following the first consultation

Primary outcomes

  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 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Registry information

Official study title

Prevalence, With Medical Imaging, of the Parenchymatous and/or Ductal Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma

Acronym: PAPAFA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2016
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.