Spectroscopy From Duodenum
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01753479|
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : March 7, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Other: Spectroscopy device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||445 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Duodenal Spectroscopy Study for Cancer Diagnosis|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
|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.
- The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort [ Time Frame: 1 year ]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 ]A receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Common inclusion criterion
- Age is 18 years or older.
- Informed consent was obtained.
- Inclusion criterion for normal cohort
- An upper GI endoscopy is scheduled to check upper abdominal symptoms.
- No findings of pancreatic disorder as documented by CT or MRI or EUS
- Inclusion criterion for PC suspicious cohort * A EUS or ERCP is scheduled to suspected pancreatic disorder.
Common exclusion criterion
- Severe cardiac disease
- Severe respiratory disease
- Bleeding disorders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753479
|United States, Florida|
|Mayo Clinic Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Texas|
|The University of Texas M. D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Bruxelles, Brussels-Capital Region, Belgium, 1070|
|Università Cattolica del Sacro Cuore|
|Rome, Lazio, Italy, 00168|
|Principal Investigator:||Michael B Wallace, M.D.||Mayo Clinic|
|Responsible Party:||Olympus Corporation|
|Other Study ID Numbers:||
|First Posted:||December 20, 2012 Key Record Dates|
|Last Update Posted:||March 7, 2017|
|Last Verified:||March 2017|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type