Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04293497
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2020-02-29
Brief Title:
Development of a New Immunochemistry Method Using Antibodies of Proteins Related Pancreatic Cancer
Sponsor:
Gangnam Severance Hospital
Organization:
Gangnam Severance Hospital
Study Overview
Official Title:
Clinical Validation of a New Immunochemistry Method Using Antibody of Methionyl-tRNA synthetase1MARS1 in the Pancreatic Cancer Cell Multicenter Prospective Study
Status:
COMPLETED
Status Verified Date:
2021-08
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:
None
Brief Summary:
Identifying the malignancy of pancreatic mass using endoscopic ultrasound-guided fine-needle aspiration EUS-FNA is important for treatment decision-making and prognosis prediction The sensitivity of EUS-FNA cytology specimens based on Papanicolaou Pap staining is low which hampers accurate diagnosis of pancreatic mass We assessed the diagnostic value of immunohistochemical IHC and immunofluorescence IF staining for methionyl-tRNA synthetase 1 MARS1
Detailed Description:
BACKGROUND AIMS The sensitivity of endoscopic ultrasound-guided aspiration cytology used to distinguish the pancreatic mass is low and clinical usefulness is not secured The aim of this study was to evaluate clinical efficacy of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using pancreatic cancer related protein expressed only in pancreatic cancer
Hypothesis The statistical significance between conventional staining method and MARS1 staining in the pancreatic cancer cells collected by endoscopic ultrasound-guided aspiration will be compared to prove the usefulness of the new staining method
Clinical study design The expression of MARS1 in the pancreatic cancer cell line obtained by endoscopic ultrasound in patients suspected of having pancreatic cancer using Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed
Hypothesis The statistical significance between conventional staining method and MARS1 staining in the pancreatic cancer cells collected by endoscopic ultrasound-guided aspiration will be compared to prove the usefulness of the new staining method
Clinical study design The expression of MARS1 in the pancreatic cancer cell line obtained by endoscopic ultrasound in patients suspected of having pancreatic cancer using Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed
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