METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors
Recruiting · NCT05794048 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Hepatic (hepatocellular carcinoma (HCC)) and pancreatic (pancreatic adenocarcinoma (ADKP); pancreatic neuroendocrine tumors (TNEP)) primary tumors are the most common malignant tumors of the hepato-bilio-pancreatic system and represent a major public health issue. At present, the management of these tumors is based on recommendations based on the existence of rudimentary prognostic and theranostics markers that do not sufficiently accurately reflect the heterogeneity of tumor biology. It therefore seems essential to identify new and more relevant markers in order to optimize the care of these patients in daily practice. Metabolic reprogramming is now recognized as an essential feature of cancer cells, allowing them to fuel and maintain their proliferation and tumor growth. Such metabolic reprogramming requires modification of several energy pathways, the most commonly recognized being the transition from energy metabolism based on oxidative phosphorylation to energy metabolism based on glycolysis, even under aerobic conditions (Warburg effect). In this context, the investigators hypothesized that the consumption of nutrients by the tumor cell differs significantly from that of the normal cell in order to support its increased energy needs, and that this important and specific metabolic reprogramming would be correlated with the histo-prognostic and theranostics factors of these tumors. Preliminary analyses on surgical resection parts conducted by the various partners in 2019 made it possible to characterize the metabolic signatures of a series of HCC and ADKP resected using the Metafora biosystems technology platform. These signatures reflect a metabolic program characteristic of these tumors, which reveal strong specificities. Similarly, a candidate signature correlating with the presence of vascular microscopic invasion has been identified in HCC, and the level of activation of glycolysis and glutaminolysis by certain ADKP cells also appears as a trait of interest vis-à-vis the aggressiveness of this cancer. Thus, the current project will aim to confirm the feasibility of identifying specific prognostic and theranostics metabolic signatures early, on biopsy samples and / or circulating blood cells.
Who can take part
Inclusion criteria
- Common criteria:
- Patient aged 18 or over
- Informed and having signed the consent to participate
- Affiliated with a social security scheme or entitled
- Patients with hepatocellular carcinoma
- Having a HCC eligible for surgical treatment (liver resection or liver transplantation) not requiring preoperative anti-tumor treatment as validated by the multidisciplinary consultation meeting for primary hepatic tumors
- OR having a HCC not eligible for curative treatment (liver resection, liver transplantation, tumor ablation), as validated by the multidisciplinary consultation meeting for primary hepatic tumors 2- Patients with pancreatic adenocarcinoma or pancreatic neuroendocrine tumor
- Having ADKP or NET eligible for surgical treatment (duodenopancreatectomy, left pancreatectomy, enucleation, central pancreatectomy, hepatic metastasectomy) with or without preoperative anti-tumor treatment as validated by the multidisciplinary consultation meeting.
- OR with an unresectable ADKP or TNEP, with only medical treatment plan as validated by the multidisciplinary consultation meeting
Exclusion criteria
- Criteria common to all patients:
- Pregnancy and lactation
- Lack of informed, written and signed consent
- Adult person subject to a legal protection measure or unable to express consent
- Patient under State Medical Aid (AME)
- Person deprived of liberty by a judicial or administrative decision
- Person undergoing psychiatric care
- Patients with hepatocellular carcinoma
- Suspicion of mixed tumor (hepatocholangiocarcinoma) or intrahepatic cholangiocarcinoma
- History of systemic or locoregional anti-tumor treatment in the target tumor
- Contraindication to a liver biopsy
- Decompensated cirrhosis 2- Patients with pancreatic adenocarcinoma or pancreatic neuroendocrine tumor
- Suspicion of mixed tumor (MINEN) or intra-pancreatic cholangiocarcinoma
- Contraindication to a pancreatic / hepatic biopsy
Where it is running
1 location listed.
- Hôpital Beaujon - Clichy, France