Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age over 18

Patient with intermediate-risk or high-risk TIPMP according to the European Study Group on Cystic Tumours of the Pancreas (3)

Signed consent to participate

Affiliation with a social security scheme, or beneficiary of such a scheme.

Disqualifiers

Pregnant or breast-feeding woman

Person in an emergency situation or unable to give consent.

Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),

Unable to undergo medical follow-up for geographical, social or psychological reasons.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

    Other intervention

    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.

Treatment groups

360 Participants
are divided into 1 treatment group
Group A: collection of blood and tumor samplesOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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