Prevalence of Pancreas AdenocarcinomasPAPAFANCT02810730
Prevalence of Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma
A study testing Pancreatic MRI in people with Prevalence of Pancreas Adenocarcinomas, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevalence of Pancreas Adenocarcinomas
- What is being tested?
- Pancreatic MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesFrance
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Clinique Convert
Bourg-en-Bresse
Infirmerie Protestante
Caluire-et-Cuire, 69300
Clinique du Val d'Ouest
Écully, 69130
Groupe Hospitalier Mutualiste des Eaux Claires
Grenoble, 38028
Centre des maladies du foie et de l'appareil digestif
Irigny
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Hôpital privé Jean Mermoz
Lyon, 69008
Clinique des Portes du Sud
Vénissieux, 69694
Hôpital de Villefranche
Villefranche-sur-Saône, 69655
About this study
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
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.
- Conditions
- Prevalence of Pancreas Adenocarcinomas
- Being tested
- Pancreatic MRI
- Keywords
- pancreas, adenocarcinoma
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic MRIProcedure or surgery
Pancreatic MRI in the 6 months following the first consultation
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Pancreatic MRI in the 6 months following the first consultation Receives: Procedure: Pancreatic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: six months after the last inclusion
Height of the lesions
Measured: six months after the last inclusion
Correlation between the data from the MRI and those from the echo endoscopy
Measured: six months after the last inclusion
Localisation of the lesions
Measured: six months after the last inclusion
Number of lesions
Measured: six months after the last inclusion
Aspect of the lesion (solid and/or liquid)
Measured: six months after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence of Pancreas AdenocarcinomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-marie Marion Audibert, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810730
- Sponsor's protocol ID
- 0502198069
- Acronym
- PAPAFA
- Status last verified
- Jan 2020
- First submitted
- 6 May 2016
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02810730
- Acronym / sponsor ID
- PAPAFA / 0502198069
- Conditions
- Prevalence of Pancreas Adenocarcinomas
- Keywords
- pancreas, adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Procedure: Pancreatic MRIPancreatic MRI in the 6 months following the first consultation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic MRIPancreatic MRI in the 6 months following the first consultation | Procedure or surgery | Single arm |
Primary outcome
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.
7 secondary outcomes
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
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
Height of the lesions
Time frame: six months after the last inclusion
Correlation between the data from the MRI and those from the echo endoscopy
Time frame: six months after the last inclusion
Localisation of the lesions
Time frame: six months after the last inclusion
Number of lesions
Time frame: six months after the last inclusion
Aspect of the lesion (solid and/or liquid)
Time frame: six months after the last inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-marie Marion Audibert study director
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic MRI in people with Prevalence of Pancreas Adenocarcinomas, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.