Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01753479
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2012-12-17
Brief Title:
Spectroscopy From Duodenum
Sponsor:
Olympus Corporation
Organization:
Olympus Corporation
Study Overview
Official Title:
Duodenal Spectroscopy Study for Cancer Diagnosis
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients
Detailed Description:
Pancreatic cancer PC is the most lethal of all major cancers with a five year survival rate of 5 While stage I and II tumors leads to an improvement in survival almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity Imaging modalities such as MRI CT EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost discomfort and complications Therefore there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient The investigators would like to look at the spectroscopy technique for pancreatic cancer diagnosis via an upper endoscopy A definite diagnosis of the patient is made with histology cytology or imaging diagnosis Therefore this study can be positioned as a feasibility study
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