HepatocarcinomaPROMETHEPNCT05794048
METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors
A study testing Hepatocellular carcinoma, Pancreatic adenocarcinoma and Pancreatic neuroendocrine tumor in people with Hepatocarcinoma and Pancreatic Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocarcinoma, Pancreatic Tumor
- What is being tested?
- Hepatocellular carcinoma, Pancreatic adenocarcinoma and Pancreatic neuroendocrine tumor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2022to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common criteria:
- Patient aged 18 or over
- Informed and having signed the consent to participate
- Affiliated with a social security scheme or entitled
- 1- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- Person undergoing psychiatric care
- 1- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Beaujon
Clichy, 92110
Valérie Paradis, MD, PhD, 01 40 87 54 63, valerie.paradis@aphp.fr
About this study
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.
Read the detailed description
Primary liver tumours (hepatocellular carcinoma (HCC)) and pancreatic tumours (pancreatic adenocarcinoma (ADKP); pancreatic neuroendocrine tumours (NETs)) are the most frequent malignant tumours of the hepatobiliopancreatic system and represent a major public health issue. One of the main lines of research for these tumors consists in the early identification of prognostic and theranostic factors to adapt the management of patients as closely as possible to the specificities of their pathology. This identification is currently sorely lacking in daily clinical practice. Thus, unlike what is done for other types of neoplastic pathologies such as breast cancer, the management of primary liver and pancreatic tumors is still often based on recommendations based on the existence of rudimentary prognostic and theranostic markers that do not reflect sufficiently faithfully the heterogeneity of tumor biology. It is therefore essential to identify new, more relevant markers in order to optimize the management of these patients in daily practice.
Metabolic reprogramming is now recognized as an essential characteristic 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 shift from energy metabolism based on oxidative phosphorylation to energy metabolism based on glycolysis, even under aerobic conditions (Warburg effect). Other metabolic pathways such as increased glutaminolysis have recently been identified. In this context, we 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 theranostic factors of these tumors. Within ADKPs, 2 molecular subtypes have been described: a very aggressive, "basal-like" subtype with increased glycolytic metabolism and metastatic properties and a "classical" subtype, better differentiated with better prognosis. The identification of these subtypes is currently only possible by RNA-seq, a technology not practiced routinely. Similarly, metabolism appears to define a subgroup of aggressive NETs. Indeed, NETs with high glucose uptake, visible on 18FDG PET-CT scan, have a worse prognosis. This type of examination also showed that there was spatial metabolic heterogeneity (primary tumor vs. metastasis) and temporal metabolic heterogeneity in these tumors and that the latter was correlated with prognosis.
Preliminary analyses conducted by the various partners in 2019 made it possible to characterize the metabolic signatures of a series of resected HCC and ADKP using Metafora biosystems' technological platform.
These signatures reflect a metabolic program characteristic of these tumors, which reveal strong specificities. Similarly, a candidate signature correlating with the presence of microscopic vascular invasion has been identified in HCC, and the level of activation of glycolysis and glutaminolysis by some ADKP cells also appears as a trait of interest vis-à-vis the aggressiveness of this cancer.
As these results were obtained on surgical resection parts, the current project will therefore aim to confirm the feasibility of identifying specific prognostic and theranostic metabolic signatures early, on biopsy sampling or circulating blood cells.
This multicenter study includes 300 patients (100 patients for each tumor type) and aims to identify a prognostic metabolic signature from tumor tissue samples of HCC, ADKP and pancreatic NETs.
- Conditions
- Hepatocarcinoma, Pancreatic Tumor
- Being tested
- Hepatocellular carcinoma, Pancreatic adenocarcinoma, Pancreatic neuroendocrine tumor
- Keywords
- Hepatocarcinoma, Pancreatic Tumor
- Medical subject headings
- Carcinoma, Hepatocellular, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatocellular carcinomaBiological
Tumor and liver biopsy
Pancreatic adenocarcinomaBiological
Tumor and pancreatic biopsy
Pancreatic neuroendocrine tumorBiological
Tumor and pancreatic biopsy
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma | Experimental | Patients with hepatocellular carcinoma Receives: Biological: Hepatocellular carcinoma |
| Pancreatic adenocarcinoma | Experimental | Patients with pancreatic adenocarcinoma Receives: Biological: Pancreatic adenocarcinoma |
| Pancreatic neuroendocrine tumor | Experimental | Patients with pancreatic neuroendocrine tumor Receives: Biological: Pancreatic neuroendocrine tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (15)
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 36 months
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.
Measured: 36 months
Identification of prognostic metabolic signatures obtained on circulating tumor cells of HCC.
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.
Measured: 24 months
Identification of prognostic metabolic signatures obtained on circulating tumor cells of ADKP
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.
Measured: 24 months
Identification of prognostic metabolic signatures, obtained on circulating tumor cells of TNEP
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.
Measured: 36 months
Identification of theranostic metabolic signatures obtained on circulating tumor cells of HCC
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.
Measured: 24 months
Identification of theranostic metabolic signatures, obtained on circulating tumor cells of ADKP
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.
Measured: 24 months
Identification of theranostic metabolic signatures, obtained on circulating tumor cells of TNEP
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.
Measured: 36 months
Identification of the metabolic profile of blood immune cells.
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.
Measured: 36 months
Study of prognostic value of metabolic profile of blood immune cells.
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.
Measured: 36 months
Study of theranostic value of metabolic profile of blood immune cells.
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.
Measured: 36 months
Comparison of metabolic profiles on biopsy sample.
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.
Measured: 36 months
Comparison of metabolic profiles on surgical specimen
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start8 Jun 2022
- Primary completion15 May 2025 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Paradis, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794048
- Sponsor's protocol ID
- APHP210017
- Acronym
- PROMETHEP
- Status last verified
- Feb 2024
- First submitted
- 17 Oct 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors
- ClinicalTrials.gov ID
- NCT05794048
- Acronym / sponsor ID
- PROMETHEP / APHP210017
- Conditions
- Hepatocarcinoma, Pancreatic Tumor
- Keywords
- Hepatocarcinoma, Pancreatic Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary liver tumours (hepatocellular carcinoma (HCC)) and pancreatic tumours (pancreatic adenocarcinoma (ADKP); pancreatic neuroendocrine tumours (NETs)) are the most frequent malignant tumours of the hepatobiliopancreatic system and represent a major public health issue. One of the main lines of research for these tumors consists in the early identification of prognostic and theranostic factors to adapt the management of patients as closely as possible to the specificities of their pathology. This identification is currently sorely lacking in daily clinical practice. Thus, unlike what is done for other types of neoplastic pathologies such as breast cancer, the management of primary liver and pancreatic tumors is still often based on recommendations based on the existence of rudimentary prognostic and theranostic markers that do not reflect sufficiently faithfully the heterogeneity of tumor biology. It is therefore essential to identify new, more relevant markers in order to optimize the management of these patients in daily practice.
Metabolic reprogramming is now recognized as an essential characteristic 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 shift from energy metabolism based on oxidative phosphorylation to energy metabolism based on glycolysis, even under aerobic conditions (Warburg effect). Other metabolic pathways such as increased glutaminolysis have recently been identified. In this context, we 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 theranostic factors of these tumors. Within ADKPs, 2 molecular subtypes have been described: a very aggressive, "basal-like" subtype with increased glycolytic metabolism and metastatic properties and a "classical" subtype, better differentiated with better prognosis. The identification of these subtypes is currently only possible by RNA-seq, a technology not practiced routinely. Similarly, metabolism appears to define a subgroup of aggressive NETs. Indeed, NETs with high glucose uptake, visible on 18FDG PET-CT scan, have a worse prognosis. This type of examination also showed that there was spatial metabolic heterogeneity (primary tumor vs. metastasis) and temporal metabolic heterogeneity in these tumors and that the latter was correlated with prognosis.
Preliminary analyses conducted by the various partners in 2019 made it possible to characterize the metabolic signatures of a series of resected HCC and ADKP using Metafora biosystems' technological platform.
These signatures reflect a metabolic program characteristic of these tumors, which reveal strong specificities. Similarly, a candidate signature correlating with the presence of microscopic vascular invasion has been identified in HCC, and the level of activation of glycolysis and glutaminolysis by some ADKP cells also appears as a trait of interest vis-à-vis the aggressiveness of this cancer.
As these results were obtained on surgical resection parts, the current project will therefore aim to confirm the feasibility of identifying specific prognostic and theranostic metabolic signatures early, on biopsy sampling or circulating blood cells.
This multicenter study includes 300 patients (100 patients for each tumor type) and aims to identify a prognostic metabolic signature from tumor tissue samples of HCC, ADKP and pancreatic NETs.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma | Experimental | Biological: Hepatocellular carcinomaPatients with hepatocellular carcinoma |
| Pancreatic adenocarcinoma | Experimental | Biological: Pancreatic adenocarcinomaPatients with pancreatic adenocarcinoma |
| Pancreatic neuroendocrine tumor | Experimental | Biological: Pancreatic neuroendocrine tumorPatients with pancreatic neuroendocrine tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient aged 18 or over
- Informed and having signed the consent to participate
- Affiliated with a social security scheme or entitled
- 1- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatocellular carcinomaTumor and liver biopsy | Biological | Hepatocellular carcinoma |
| Pancreatic adenocarcinomaTumor and pancreatic biopsy | Biological | Pancreatic adenocarcinoma |
| Pancreatic neuroendocrine tumorTumor and pancreatic biopsy | Biological | Pancreatic neuroendocrine tumor |
Primary outcome
Prognostic metabolic signatures of HCC
Time frame: 24 months
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.
Prognostic metabolic signatures of ADKP
Time frame: 36 months
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.
Prognostic metabolic signatures of TNEP.
Time frame: 24 months
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.
Theranostic metabolic signatures of HCC.
Time frame: 24 months
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.
Theranostic metabolic signatures of ADKP.
Time frame: 36 months
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.
Theranostic metabolic signatures of TNEP.
Time frame: 24 months
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.
15 secondary outcomes
Identification of circulating HCC tumor cells based on detection of their metabolic profile
Time frame: 24 months
Identification of circulating ADKP tumor cells based on detection of their metabolic profile
Time frame: 24 months
Identification of circulating TNEP tumor cells based on detection of their metabolic profile
Time frame: 36 months
Comparison of circulating tumor cells with detection based solely on an epithelial marker
Time frame: 36 months
Identification of prognostic metabolic signatures obtained on circulating tumor cells of HCC.
Time frame: 24 months
Identification of prognostic metabolic signatures obtained on circulating tumor cells of ADKP
Time frame: 24 months
Identification of prognostic metabolic signatures, obtained on circulating tumor cells of TNEP
Time frame: 36 months
Identification of theranostic metabolic signatures obtained on circulating tumor cells of HCC
Time frame: 24 months
Identification of theranostic metabolic signatures, obtained on circulating tumor cells of ADKP
Time frame: 24 months
Identification of theranostic metabolic signatures, obtained on circulating tumor cells of TNEP
Time frame: 36 months
Identification of the metabolic profile of blood immune cells.
Time frame: 36 months
Study of prognostic value of metabolic profile of blood immune cells.
Time frame: 36 months
Study of theranostic value of metabolic profile of blood immune cells.
Time frame: 36 months
Comparison of metabolic profiles on biopsy sample.
Time frame: 36 months
Comparison of metabolic profiles on surgical specimen
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Paradis, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatocellular carcinoma, Pancreatic adenocarcinoma and Pancreatic neuroendocrine tumor in people with Hepatocarcinoma and Pancreatic Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie Paradis, MD, PhD (01 40 87 54 63, valerie.paradis@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic metabolic signatures of HCC (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.