Pancreatic DiseasesPACTOLNCT05824403
PAncreatic Disease Cohort of TOuLouse
An observational study of Pancreatic Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Diseases
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with pancreatic disease
Who may be able to join
- Patients with inflammatory or cystic exocrine pancreatic pathology
- Patient able to read and understand the information leaflet
- Patients who have agreed to participate in the study and have signed the free and informed consent
- Patients affiliated to a social security system (including AME)
Who cannot join
- Patient with pancreatic cancer pathology
- Patients with active cancer, whatever the origin
- Pregnant or breastfeeding patients
- Patients under legal protection, guardianship or trusteeship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rangueil hospital
Toulouse
Barbara BOURNET, MD, 0561323235, bournet.b@chu-toulouse.fr
Adrian CULETTO, MD
About this study
This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.
Read the detailed description
This collection focuses on pathology of the pancreas requiring specific investigations or management for diagnosis or treatment. Pancreatic pathologies can be classified as malignant, potentially malignant or benign tumors. These can be solid or cystic. There is an inflammatory attack on the pancreas, generating acute pancreatitis in the acute period, if the inflammatory manifestations persist, chronic pancreatitis will develop. Some lesions may be at risk of malignancy during their evolution, it is therefore necessary to improve the performance of monitoring and diagnostic tools in order to adapt the management of patients.
- Conditions
- Pancreatic Diseases
- Keywords
- Pancreatic cyst, Acute pancreatitis, chronic pancreatitis, Intra Pancreatic Mucinous Neoplasia, diagnosis
- Medical subject headings
- Pancreatic Diseases, Pancreatic Cyst, Pancreatitis, Pancreatitis, Chronic, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic tools
To develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies
Measured: 3 years after the first inclusion
Secondary outcomes (4)
New targets
To identify new screening targets
Measured: 3 years after the first inclusion
Improvement of management
To improve the management of cystic lesions or Chronic pancreatitis on the decision of therapeutic management
Measured: 3 years after the first inclusion
Microbiota
Study of the microbiota of pancreatic diseases
Measured: 3 years after the first inclusion
Clinical data access
To make available to the scientific community quality material with associated clinical data also of quality
Measured: 3 years after the first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start28 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara BOURNET, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824403
- Sponsor's protocol ID
- RC31/22/0530
- Acronym
- PACTOL
- Status last verified
- Nov 2023
- First submitted
- 27 Mar 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bardol T, Dujon AM, Taly V, Dunyach-Remy C, Lavigne JP, Costa-Silva B, Kurma K, Eslami-S Z, Cayrefourcq L, Canivet C, Muscari F, Bournet B, Alix-Panabieres C. Early detection of pancreatic cancer by liquid biopsy "PANLIPSY": a french nation-wide study project. BMC Cancer. 2024 Jun 10;24(1):709. doi: 10.1186/s12885-024-12463-8.
PubMed 38853244
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAncreatic Disease Cohort of TOuLouse
- ClinicalTrials.gov ID
- NCT05824403
- Acronym / sponsor ID
- PACTOL / RC31/22/0530
- Conditions
- Pancreatic Diseases
- Keywords
- Pancreatic cyst, Acute pancreatitis, chronic pancreatitis, Intra Pancreatic Mucinous Neoplasia, diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Apr 2023 (actual)
- 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.
This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.
Detailed description
This collection focuses on pathology of the pancreas requiring specific investigations or management for diagnosis or treatment. Pancreatic pathologies can be classified as malignant, potentially malignant or benign tumors. These can be solid or cystic. There is an inflammatory attack on the pancreas, generating acute pancreatitis in the acute period, if the inflammatory manifestations persist, chronic pancreatitis will develop. Some lesions may be at risk of malignancy during their evolution, it is therefore necessary to improve the performance of monitoring and diagnostic tools in order to adapt the management of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic disease
Key inclusion criteria (4 listed)
- Patients with inflammatory or cystic exocrine pancreatic pathology
- Patient able to read and understand the information leaflet
- Patients who have agreed to participate in the study and have signed the free and informed consent
- Patients affiliated to a social security system (including AME)
Key exclusion criteria (4 listed)
- Patient with pancreatic cancer pathology
- Patients with active cancer, whatever the origin
- Pregnant or breastfeeding patients
- Patients under legal protection, guardianship or trusteeship
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
Diagnostic tools
Time frame: 3 years after the first inclusion
To develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies
4 secondary outcomes
New targets
Time frame: 3 years after the first inclusion
Improvement of management
Time frame: 3 years after the first inclusion
Microbiota
Time frame: 3 years after the first inclusion
Clinical data access
Time frame: 3 years after the first inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 38853244Bardol T, Dujon AM, Taly V, Dunyach-Remy C, Lavigne JP, Costa-Silva B, Kurma K, Eslami-S Z, Cayrefourcq L, Canivet C, Muscari F, Bournet B, Alix-Panabieres C. Early detection of pancreatic cancer by liquid biopsy "PANLIPSY": a french nation-wide study project. BMC Cancer. 2024 Jun 10;24(1):709. doi: 10.1186/s12885-024-12463-8.
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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.
Barbara BOURNET, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Diseases, run by University Hospital, Toulouse at 1 site 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara BOURNET, MD (0561323235 ext. +33, bournet.b@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic tools (time frame: 3 years after the first inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05824403, which also lists 1 linked publication.
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 4 Dec 2023.