Pancreas CancerCaPaLongNCT04436679
INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors
An observational study of Pancreas Cancer and Pancreatic Adenocarcinoma, run by University Hospital, Lille at 1 site in France.
Trial summary
The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Adenocarcinoma
- How many people
- 342 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to 22 Feb 2025
- 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: Pancreatic adenocarcinoma patients operated on between 2001 and 2016.
Who may be able to join
- Patients > 18 years of age at diagnosis
- Primary pancreatic cancer patients operated on in one of the 4 centres between 2001 and 2016
- Histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas, ductal adenocarcinoma or classical adenocarcinoma
- Tissue blocks (FFPE) available (tumour/healthy tissue)
- Affiliated to a social security scheme
Who cannot join
- Absence of Primary Cancer Tissue Blocks (PCTBs)
- Paraffin block fixed in Bouin or AFA
- Patient Refusal
- Pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine tumor/carcinoma, acinar cell carcinoma, ...).
- Patient died due to post-surgical complications (death within 30 days post-surgery).
- Surgical resection of macroscopic R2 type.
Trial locations and contacts
1 site in 1 country.
About this study
The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.
- Conditions
- Pancreas Cancer, Pancreatic Adenocarcinoma
- Keywords
- survival, prognosis, tissue, pancreas cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival.
Tissue analysis will be performed by conventional microscopy and will evaluate histological markers known in the literature to have a prognostic impact.
Measured: at 2 years
Secondary outcomes (1)
Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival.
Immunohistochemistry tissue analysis. It will allow the evaluation of newly described histological markers for pancreatic adenocarcinoma, which could have a prognostic impact such as the immunophenotype of the inflammatory infiltrate, the expression of the mucins MUC1, MUC5AC, MUC4, MUC16, mesothelin, p53, Ki67 (MIB1) and markers of aggressive subtypes identified by transcriptome studies, in particular the basal-like molecular subtype.
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start2 Feb 2021
- Primary completion22 Feb 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Retrospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Leteurtre, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436679
- Sponsor's protocol ID
- 2019_29
- Other IDs
- 2019-A02001-56
- Acronym
- CaPaLong
- Status last verified
- Mar 2025
- First submitted
- 15 Jun 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors
- ClinicalTrials.gov ID
- NCT04436679
- Acronym / sponsor ID
- CaPaLong / 2019_29
- Conditions
- Pancreas Cancer, Pancreatic Adenocarcinoma
- Keywords
- survival, prognosis, tissue, pancreas cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 18 Jun 2020 (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.
The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic adenocarcinoma patients operated on between 2001 and 2016.
Key inclusion criteria (5 listed)
- Patients > 18 years of age at diagnosis
- Primary pancreatic cancer patients operated on in one of the 4 centres between 2001 and 2016
- Histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas, ductal adenocarcinoma or classical adenocarcinoma
- Tissue blocks (FFPE) available (tumour/healthy tissue)
- Affiliated to a social security scheme
Key exclusion criteria (6 listed)
- Absence of Primary Cancer Tissue Blocks (PCTBs)
- Paraffin block fixed in Bouin or AFA
- Patient Refusal
- Pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine tumor/carcinoma, acinar cell carcinoma, ...).
- Patient died due to post-surgical complications (death within 30 days post-surgery).
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
Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival.
Time frame: at 2 years
Tissue analysis will be performed by conventional microscopy and will evaluate histological markers known in the literature to have a prognostic impact.
1 secondary outcome
Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival.
Time frame: at 2 years
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 30 Mar 2025.
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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.
Emmanuelle Leteurtre, MD,PhD principal investigator
University Hospital, Lille
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 Pancreas Cancer and Pancreatic Adenocarcinoma, run by University Hospital, Lille 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 5 inclusion and 6 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 30 Mar 2025. 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?
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?
Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival. (time frame: at 2 years). 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 30 Mar 2025.