Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549725
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Clinical Performance of Medical Device Software Lipidica 10 for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Performance of Medical Device Software Lipidica 10 for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Software Lipidica is intended to be used for processing data generated by the in-house in vitro diagnostic medical device for lipidomic testing for the purpose of screening Pancreatic cancer PaC in the population at high risk of this cancer due to familial risk selected gene mutations or hereditary pancreatic diseases
The primary objective is to verify that the investigational MDSW can discriminate between results of patients with Pancreatic cancer and persons without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions
Participants will
come to baseline and end of study visit for blood sampling and medical imaging
some participant will undertake one more visit depending on their results on baseline
The primary objective is to verify that the investigational MDSW can discriminate between results of patients with Pancreatic cancer and persons without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions
Participants will
come to baseline and end of study visit for blood sampling and medical imaging
some participant will undertake one more visit depending on their results on baseline
Detailed Description:
Pancreatic cancer PaC is one of the cancer diseases with the worst prognosis as mortality almost equals the incidence In the Czech Republic the incidence of pancreatic ductal adenocarcinoma PDAC has had a clear upward trend since the late 1970s and in 2018 219 new cases per 100000 persons were reported
PDAC is associated with a poor prognosis for several reasons Due to the usual asymptomatic course or occurrence of only non-specific symptoms it is usually detected in an advanced stage Moreover the diagnosis by standard methods can be difficult in the early stages and investigators lack sensitive and specific tumor markers The disease forms distant metastases rapidly which creates a very short time interval for effective curative interventions So far PaC screening possibilities in the Czech Republic are limited to several academic research screening cohorts
Five-year survival regardless of clinical stage is 7-9 The resectable disease is detected in 10 of patients with a 5-year survival of 42 Locally advanced unresectable disease is found in about 30 of patients with a 5-year survival of 12 and metastatic disease is diagnosed in about 60 of patients with a 5-year survival of only approx 3
PaC screening is not suitable for an unselected population By contrast it is vital for individuals with a high risk of developing this disease due to family history andor genetic predispositions Early diagnosis resulted in more curative resections and longer survival in this population thanks to the screening programs First economic evaluations described the possible cost-effectiveness of screening high-risk individuals
Changes in plasma lipid concentrations were reported in various cancer types bladder breast colorectal gastric liver kidney lung oesophageal ovarian prostate thyroid and pancreas The altered plasma lipid profile may originate not only from tumor cells tumor stroma and apoptotic cells but also from an immune response
Previous study robustly proved a specific lipidomic phenotype in patients with PDAC across stages age treatments or the presence of diabetes Multiple lipid species were significantly downregulated in the plasma of PDAC patients such as very long-chain monounsaturated sphingomyelins ceramides and lysophosphatidylcholines The study showed that lipid profiling can discriminate between patients with PDAC and healthy controls or patients with pancreatitis This clinical performance study CPS follows on from the previous study by Wolrab et al
PDAC is associated with a poor prognosis for several reasons Due to the usual asymptomatic course or occurrence of only non-specific symptoms it is usually detected in an advanced stage Moreover the diagnosis by standard methods can be difficult in the early stages and investigators lack sensitive and specific tumor markers The disease forms distant metastases rapidly which creates a very short time interval for effective curative interventions So far PaC screening possibilities in the Czech Republic are limited to several academic research screening cohorts
Five-year survival regardless of clinical stage is 7-9 The resectable disease is detected in 10 of patients with a 5-year survival of 42 Locally advanced unresectable disease is found in about 30 of patients with a 5-year survival of 12 and metastatic disease is diagnosed in about 60 of patients with a 5-year survival of only approx 3
PaC screening is not suitable for an unselected population By contrast it is vital for individuals with a high risk of developing this disease due to family history andor genetic predispositions Early diagnosis resulted in more curative resections and longer survival in this population thanks to the screening programs First economic evaluations described the possible cost-effectiveness of screening high-risk individuals
Changes in plasma lipid concentrations were reported in various cancer types bladder breast colorectal gastric liver kidney lung oesophageal ovarian prostate thyroid and pancreas The altered plasma lipid profile may originate not only from tumor cells tumor stroma and apoptotic cells but also from an immune response
Previous study robustly proved a specific lipidomic phenotype in patients with PDAC across stages age treatments or the presence of diabetes Multiple lipid species were significantly downregulated in the plasma of PDAC patients such as very long-chain monounsaturated sphingomyelins ceramides and lysophosphatidylcholines The study showed that lipid profiling can discriminate between patients with PDAC and healthy controls or patients with pancreatitis This clinical performance study CPS follows on from the previous study by Wolrab et al
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None