Pancreatic AdenocarcinomaAPACHNCT01989624
PAncreatic Adenocarcinoma in Hospital
An observational study of Pancreatic Adenocarcinoma, run by Centre Hospitalier Departemental Vendee at 66 sites in 2 countries.
Trial summary
Few data are currently available in the literature on pancreatic adenocarcinoma in France. About 8,000 new cases each year in France. The 5-year survival for all stages combined is <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- How many people
- 1,204 participants
- Where
- 66 sitesin 2 countries
- Study dates
- 18 Oct 2013to Dec 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient in hepatogastroenterology in general hospital
Who may be able to join
- Living in France
- Pancreatic adenocarcinoma histologically or cytologically proven
- primary diagnosis
- Agreed to participate
Who cannot join
- Suspected pancreatic adenocarcinoma histologically or cytologically unproven
- Refused to participate
Trial locations and contacts
66 sites in 2 countries.
66 sites in 2 countries
France65 sites
CHIAP
Aix-en-Provence, 13616
CH Angoulême
Angoulême
CH d'Aubenas
Aubenas, 07200
CH Auch
Auch, 32008
CH Robert Ballanger
Aulnay-sous-Bois
CH Avignon
Avignon
CH Bagnols sur Ceze
Bagnols-sur-Cèze
CH Bayeux
Bayeux, 14400
CH Béziers
Béziers, 34500
CH Blois
Blois, 41016
CH Bourg en Bresse
Bourg-en-Bresse
CH de Bourges
Bourges, 18000
CH Nord Deux Sèvres
Bressuire
CH Saint Camille
Bry-sur-Marne
HPA Castres Mazamet
Castres, 81108
CH Chalons en champagne
Châlons-en-Champagne
CH Chambery
Chambéry
CH Chartres
Chartres, 28630
CH Haut Anjou
Château-Gontier
CH Châteauroux
Châteauroux, 36000
Ch Cholet
Cholet
CH Compiègne Noyon
Compiègne
CH sud francilien
Corbeil-Essonnes
CH de Creil
Creil, 60109
CHI Créteil
Créteil, 94000
CH Dourdan
Dourdan
CH Draguignan
Draguignan
CH Dreux
Dreux, 28100
CH Simone Veil
Eaubonne, 95600
CH Forcilles
Férolles
Chicas
Gap
CH Gonesse
Gonesse, 95500
Centre hospitalier départemental Vendée
La Roche-sur-Yon, 85925
Centre Hospitalier de Lagny
Lagny-sur-Marne, 77400
CH du Mans
Le Mans
Lens
Lens
Centre Hospitalier Côté de lumière
Les Sables-d'Olonne, 85100
Hôpital des chanaux
Mâcon
Centre Hospitalier de Meaux
Meaux, 77100
CH Melun
Melun
CHR de Mercy-Metz
Metz
CHAM
Montargis, 45207
CH Montauban
Montauban
Centre Hospitalier Montelimar
Montélimar, 26200
CH Montfermeil
Montfermeil
CH Niort
Niort
CHG Oloron
Oloron-Sainte-Marie
CHR Orléans
Orléans, 45000
CH François Mitterand
Pau
Centre Hospitalier de Perpignan
Perpignan, 66046
CHI Poissy Saint Germain
Poissy, 78600
CH Pontoise
Pontoise
CH de la région d'Annecy
Pringy, 74374
CH Quimper
Quimper, 29107
CH Roubaix
Roubaix
Centre hospitalier Yves Le Foll
Saint-Brieuc, 22200
CH de la Fontaine
Saint-Denis
CH Gabriel Martin
Saint-Paul, La Réunion, 97866
CH Saint Quentin
Saint-Quentin
Centre Hospitalier de Bigorre
Tarbes, 65013
CH Sainte Musse
Toulon
CH Tourcoing
Tourcoing
CH Valenciennes
Valenciennes
CHBA de Vannes
Vannes, 56017
CHIV Villeneuve Saint-Georges
Villeneuve-Saint-Georges, 94190
About this study
Few data are currently available in the literature on pancreatic adenocarcinoma in France. About 8,000 new cases each year in France. The 5-year survival for all stages combined is <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%.
Epidemiological characteristics at diagnosis, the impact on the survival of recent advances related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy (FOLFIRINOX) are mispriced in real life.
Read more
The development of new drugs and the development of Phase II and III require a better understanding of the state of this disease in the country.
The main objective is to describe the characteristics of the pancreatic adenocarcinoma at diagnosis in France and make an inventory of diagnostic practices and support.
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic adenocarcinoma, diagnosis, treatment
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Adenocarcinoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: patient death (following during 5 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study start18 Oct 2013
- Primary completion4 Dec 2015
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger FAROUX, PH, Principal investigator, Centre hospitalier départemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989624
- Sponsor's protocol ID
- CHD064-13
- Acronym
- APACH
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2013
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAncreatic Adenocarcinoma in Hospital
- ClinicalTrials.gov ID
- NCT01989624
- Acronym / sponsor ID
- APACH / CHD064-13
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic adenocarcinoma, diagnosis, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,204 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- 4 Dec 2015 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 21 Nov 2013 (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.
Few data are currently available in the literature on pancreatic adenocarcinoma in France. About 8,000 new cases each year in France. The 5-year survival for all stages combined is <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%.
Epidemiological characteristics at diagnosis, the impact on the survival of recent advances related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy (FOLFIRINOX) are mispriced in real life.
The development of new drugs and the development of Phase II and III require a better understanding of the state of this disease in the country.
The main objective is to describe the characteristics of the pancreatic adenocarcinoma at diagnosis in France and make an inventory of diagnostic practices and support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Adenocarcinoma | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient in hepatogastroenterology in general hospital
Key inclusion criteria (4 listed)
- Living in France
- Pancreatic adenocarcinoma histologically or cytologically proven
- primary diagnosis
- Agreed to participate
Key exclusion criteria (2 listed)
- Suspected pancreatic adenocarcinoma histologically or cytologically unproven
- Refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: patient death (following during 5 year)
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 14 Mar 2022.
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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.
Roger FAROUX, PH principal investigator
Centre hospitalier départemental Vendée
66 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma, run by Centre Hospitalier Departemental Vendee at 66 sites in 2 countries.
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 4 inclusion and 2 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 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in France, Belgium. 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?
Survival (time frame: patient death (following during 5 year)). 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 14 Mar 2022.