Spectroscopy From Duodenum
Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Duodenal Spectroscopy Study for Cancer Diagnosis|
- The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort [ Time Frame: 1 year ] [ Designated as safety issue: No ]To clarify that there is the statistically-significant difference between two cohorts.
- The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants. [ Time Frame: 1 year ] [ Designated as safety issue: No ]A receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
|Experimental: Test subject||
Other: Spectroscopy device
Spectrum data are collected using spectroscopy device via an instrumental channel of endoscope. Then spectrum data is analyzed. Numerical features (spectral slope and width of spectrum) are used for statistical analysis.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753479
|Contact: Michael B Wallace, M.D.||(904)953-7382||Wallace.Michael@mayo.edu|
|United States, Florida|
|Mayo Clinic Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Michael B Wallace, M.D. 904-953-7382 Wallace.Michael@mayo.edu|
|United States, Texas|
|The University of Texas M. D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Bruxelles, Brussels-Capital Region, Belgium, 1070|
|Università Cattolica del Sacro Cuore||Recruiting|
|Rome, Lazio, Italy, 00168|
|Principal Investigator:||Michael B Wallace, M.D.||Mayo Clinic Florida|