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Trial Title:
Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas
NCT ID:
NCT06000553
Condition:
PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
the patient takes specific blood samples for the study
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
blood sampling at inclusion, 6 months, 1 year and 2 years. Tumor and intracystic fluid samples are taken only if a biopsy is planned following MRI results.
Description:
If the patient agrees to take part in the study, he or she will have a blood sample taken
from 8 x 4 ml EDTA tubes at the time of inclusion in the trial.Then, at 6 months (+/- 1
month), 1 year and 2 years, the patient will have the same blood sample as at
inclusion.If a biopsy is performed as part of routine care, a tumor sample will be taken
and sent to the IPC pathology department for FFPE block. If a biopsy is performed and the
patient consents, a cystic fluid sample will be taken.
Arm group label:
collection of blood and tumor samples
Summary:
This trial is a prospective, exploratory and descriptive study. The primary objective is
to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of
Treg lymphocyte subpopulations and epigenetic signatures, and the secondary objective is
to characterize the biological processes underlying the transformation of a
pre-neoplastic lesion into established ADPC.
Detailed description:
To meet the objectives of the study, patients will have blood samples taken at the time
of their TIPMP monitoring, i.e. at inclusion, 6 months, 1 year and 2 years. If
echo-endoscopy is performed during MRI monitoring of their disease, and a sample is taken
as part of the treatment, a tumor sample and an intra-cystic fluid sample will be
collected as part of the protocol.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age over 18
2. Patient with intermediate-risk or high-risk TIPMP according to the European Study
Group on Cystic Tumours of the Pancreas (3)
3. Signed consent to participate
4. Affiliation with a social security scheme, or beneficiary of such a scheme.
Exclusion Criteria:
1. Pregnant or breast-feeding woman
2. Person in an emergency situation or unable to give consent.
3. Adult subject to a legal protection measure (adult under guardianship, curatorship
or safeguard of justice),
4. Unable to undergo medical follow-up for geographical, social or psychological
reasons.
5. contraindication to MRI.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 30, 2023
Completion date:
October 30, 2028
Lead sponsor:
Agency:
Institut Paoli-Calmettes
Agency class:
Other
Source:
Institut Paoli-Calmettes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06000553
