METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors

NCT05794048 | Recruiting

• 1 other identifier: APHP210017
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocarcinoma; Pancreatic Tumor

Keywords

Hepatocarcinoma; Pancreatic Tumor

Outcome Measures

Primary Outcomes (6)

• 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.

  24 months

• 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.

  36 months

• 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.

  24 months

• 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.

  24 months

• Theranostic metabolic signatures of ADKP.

  Identify theranostic 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.

  36 months

• Theranostic metabolic signatures of TNEP.

  Identify theranostic 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.

  24 months

Secondary Outcomes (15)

• Identification of circulating HCC tumor cells based on detection of their metabolic profile

  24 months

• Identification of circulating ADKP tumor cells based on detection of their metabolic profile

  24 months

• Identification of circulating TNEP tumor cells based on detection of their metabolic profile

  36 months

• Comparison of circulating tumor cells with detection based solely on an epithelial marker

  36 months

• Identification of prognostic metabolic signatures obtained on circulating tumor cells of HCC.

  24 months

Study Arms (3)

Hepatocellular carcinoma

EXPERIMENTAL

Patients with hepatocellular carcinoma

Biological: Hepatocellular carcinoma

Pancreatic adenocarcinoma

EXPERIMENTAL

Patients with pancreatic adenocarcinoma

Biological: Pancreatic adenocarcinoma

Pancreatic neuroendocrine tumor

EXPERIMENTAL

Patients with pancreatic neuroendocrine tumor

Biological: Pancreatic neuroendocrine tumor

Interventions

Hepatocellular carcinoma BIOLOGICAL

Tumor and liver biopsy

Hepatocellular carcinoma

Pancreatic adenocarcinoma BIOLOGICAL

Tumor and pancreatic biopsy

Pancreatic adenocarcinoma

Pancreatic neuroendocrine tumor BIOLOGICAL

Tumor and pancreatic biopsy

Pancreatic neuroendocrine tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Valérie Paradis, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Paradis, MD, PhD

CONTACT

01 40 87 54 63; valerie.paradis@aphp.fr

François Cauchy, MD, PhD

CONTACT

01 40 87 52 62; francois.cauchy@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: March 31, 2023
• Study Start: June 8, 2022
• Primary Completion: May 15, 2025
• Study Completion (Estimated): September 8, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

FR (1)