Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430021
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-05-21
Brief Title:
Study of the Value of hPG80 Circulating Progastrin for the Diagnosis of Neuroendocrine Tumours in Patients With an MEN1 Mutation
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Study of the Value of hPG80 Circulating Progastrin for the Diagnosis of Neuroendocrine Tumours in Patients With an NEM1 Mutation the Progastrin-NEM1 Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-NEM1
Brief Summary:
Multiple Endocrine Neoplasia type 1 MEN1 is an autosomal dominant disease with a high degree of penetrance 80 of patients It is caused by the presence of the MEN1 mutation located on chromosome 11q13 The prevalence of this mutation is estimated at approximately 130000 This hereditary syndrome is characterized by the presence of tumours of the endocrine system adenoma of the parathyroid pituitary and adrenal glands neuroendocrine tumors - NETs - of the endocrine pancreas duodenum lung or thymus which threaten the health of these patients Other malignant tumors such as breast cancer are also more common in patients with MEN1
The clinical manifestations of MEN1 are linked to the location of the adenomas and NETs and their secretory products Indeed most NETs produce and secrete numerous peptide hormones in the case of Insulinomas Gastrinomas VIPomas Glucagonomas or PPomas for example This causes a specific clinical syndrome which can be detected in the blood serum However most NETs are non-functional tumors which do not have specific secretions
Among general tumor markers chromogranin A CgA is widely used as a biomarker for monitoring NETs CgA is a secretory protein released into the blood by neuroendocrine cells However the performance of CgA as a diagnostic biomarker is too limited to be used for the early identification of NETs particularly in patients with MEN1
This is why patients with MEN1 undergo regular biological and morphological examinations at least once a year to screen for the development of adenomas and NETs However CgA or hormone secretions assays and imaging examinations MRI CT scan or duodenopancratic endoscopic ultrasound EUS are tedious and stressful for patients in addition they all have their limitations poor performance for biological tests irradiation for CT scan need for anesthesia for endoscopic ultrasound etc Consequently there is a need for new markers to identify NETs in this population as early as possible
Progastrin is a pro-hormone that under physiological conditions is matured into gastrin in the G cells of the antrum of the stomach The role of gastrin is to stimulate gastric acid secretion during digestion It also plays an important role in regulating cell growth in the gastric mucosa In pathological situations it has been shown that the GAST gene which codes for progastrin is over-expressed in human tumor cells of different origins leading to the accumulation of progastrin within them Tumor cells that are unable to mature progastrin into gastrin either because the maturation enzymes are not expressed or are inhibited will secrete it This circulating progastrin is then called hPG80 to differentiate it from intracellular progastrin and is detectable in patient blood hPG80 is a new biomarker for the detection of different types of cancer It appears to be elevated in the early stages of the disease potentially more so than other biomarkers such as circulating tumor DNA ctDNA or NETest In addition hPG80 is easily measured in plasma using the DxPG80Lab ELISA Progastrin Manufacturing The analytical characteristics of this CE-marked in vitro diagnostic test have been published in the Analytical Methods journal It has been validated in numerous studies of various cancers including NET patients In addition a study conducted by the team at Progastrin Manufacturing formerly ECS-Progastrin showed that hPG80 was unequivocally present in the peripheral blood of patients with 11 different types of cancer with a concentration significantly higher than that found in blood donors considered to be healthy We therefore hypothesize that hPG80 could also be a biomarker for NETs in MEN1
The clinical manifestations of MEN1 are linked to the location of the adenomas and NETs and their secretory products Indeed most NETs produce and secrete numerous peptide hormones in the case of Insulinomas Gastrinomas VIPomas Glucagonomas or PPomas for example This causes a specific clinical syndrome which can be detected in the blood serum However most NETs are non-functional tumors which do not have specific secretions
Among general tumor markers chromogranin A CgA is widely used as a biomarker for monitoring NETs CgA is a secretory protein released into the blood by neuroendocrine cells However the performance of CgA as a diagnostic biomarker is too limited to be used for the early identification of NETs particularly in patients with MEN1
This is why patients with MEN1 undergo regular biological and morphological examinations at least once a year to screen for the development of adenomas and NETs However CgA or hormone secretions assays and imaging examinations MRI CT scan or duodenopancratic endoscopic ultrasound EUS are tedious and stressful for patients in addition they all have their limitations poor performance for biological tests irradiation for CT scan need for anesthesia for endoscopic ultrasound etc Consequently there is a need for new markers to identify NETs in this population as early as possible
Progastrin is a pro-hormone that under physiological conditions is matured into gastrin in the G cells of the antrum of the stomach The role of gastrin is to stimulate gastric acid secretion during digestion It also plays an important role in regulating cell growth in the gastric mucosa In pathological situations it has been shown that the GAST gene which codes for progastrin is over-expressed in human tumor cells of different origins leading to the accumulation of progastrin within them Tumor cells that are unable to mature progastrin into gastrin either because the maturation enzymes are not expressed or are inhibited will secrete it This circulating progastrin is then called hPG80 to differentiate it from intracellular progastrin and is detectable in patient blood hPG80 is a new biomarker for the detection of different types of cancer It appears to be elevated in the early stages of the disease potentially more so than other biomarkers such as circulating tumor DNA ctDNA or NETest In addition hPG80 is easily measured in plasma using the DxPG80Lab ELISA Progastrin Manufacturing The analytical characteristics of this CE-marked in vitro diagnostic test have been published in the Analytical Methods journal It has been validated in numerous studies of various cancers including NET patients In addition a study conducted by the team at Progastrin Manufacturing formerly ECS-Progastrin showed that hPG80 was unequivocally present in the peripheral blood of patients with 11 different types of cancer with a concentration significantly higher than that found in blood donors considered to be healthy We therefore hypothesize that hPG80 could also be a biomarker for NETs in MEN1
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None