An interventional study of 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. in PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS, sponsored by Institut Paoli-Calmettes. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Other
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 360 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Other: 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.
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.
the aim is to search for immune and metabolic abnormalities in patients with at-risk TIPMP in the blood or by echo-endoscopic sampling, then compare and combine them with the criteria used in clinical practice.
Biomarkers will be studied to determine whether those selected have been effective in identifying patients with pancreatic adenocarcinoma.
Time frame: for two years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Institut Paoli-Calmettes