METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 or over
Informed and having signed the consent to participate
Affiliated with a social security scheme or entitled
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Hepatocellular carcinoma
Biological/VaccineTumor and liver biopsy
Pancreatic adenocarcinoma
Biological/VaccineTumor and pancreatic biopsy
Pancreatic neuroendocrine tumor
Biological/VaccineTumor and pancreatic biopsy
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Hepatocellular carcinomaExperimental treatment 1 intervention
Group B: Pancreatic adenocarcinomaExperimental treatment 1 intervention
Group C: Pancreatic neuroendocrine tumorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Prognostic metabolic signatures of HCC
Identify prognostic metabolic signatures obtained from operative specimens and biopsies of hepatocellular carcinoma (HCC). As this is an exploratory pilot study, it does not include primary and secondary endpoints. Metabolic signatures will be statistically processed to correlate with clinical prognosis.
Time frame
24 months2
Prognostic metabolic signatures of ADKP
Identify prognostic metabolic signatures obtained from operative specimens and biopsies of pancreatic adenocarcinoma (ADKP). As this is an exploratory pilot study, it does not include primary and secondary endpoints. Metabolic signatures will be statistically processed to correlate with clinical prognosis.
Time frame
36 months3
Prognostic metabolic signatures of TNEP.
Identify prognostic metabolic signatures obtained from operative specimens and biopsies of pancreatic neuroendocrine tumors (TNEP). As this is an exploratory pilot study, it does not include primary and secondary endpoints. Metabolic signatures will be statistically processed to correlate with clinical prognosis.
Time frame
24 months4
Theranostic metabolic signatures of HCC.
Identify theranostic metabolic signatures obtained from operative specimens and biopsies of hepatocellular carcinoma (HCC). As this is an exploratory pilot study, it does not include primary and secondary endpoints. Metabolic signatures will be statistically processed to correlate with clinical prognosis.
Time frame
24 monthsSecondary outcomes
1
Identification of circulating HCC tumor cells based on detection of their metabolic profile
As this is a pilot study, these metabolic signatures will then be statistically processed to correlate them with clinical prognosis; This is not an evaluation criterion stricto sensu.
Time frame
24 months2
Identification of circulating ADKP tumor cells based on detection of their metabolic profile
As this is a pilot study, these metabolic signatures will then be statistically processed to correlate them with clinical prognosis; This is not an evaluation criterion stricto sensu.
Time frame
24 months3
Identification of circulating TNEP tumor cells based on detection of their metabolic profile
As this is a pilot study, these metabolic signatures will then be statistically processed to correlate them with clinical prognosis; This is not an evaluation criterion stricto sensu.
Time frame
36 months4
Comparison of circulating tumor cells with detection based solely on an epithelial marker
As this is a pilot study, these metabolic signatures will then be statistically processed to correlate them with clinical prognosis; This is not an evaluation criterion stricto sensu.
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov