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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
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Catholic University of the Sacred Heart
Erasme University Hospital
Information provided by (Responsible Party):
Olympus Corporation

Tracking Information
First Submitted Date  ICMJE December 17, 2012
First Posted Date  ICMJE December 20, 2012
Last Update Posted Date March 7, 2017
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2012)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2012)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spectroscopy From Duodenum
Official Title  ICMJE Duodenal Spectroscopy Study for Cancer Diagnosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pancreatic Adenocarcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Test subject
Intervention: Other: Spectroscopy device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2017)		 445
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2012)		 250
Actual Study Completion Date  ICMJE June 30, 2016
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Common exclusion criterion

    • Severe cardiac disease
    • Severe respiratory disease
    • Bleeding disorders
    • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01753479
Other Study ID Numbers  ICMJE OMSC-Mag-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Olympus Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Olympus Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • M.D. Anderson Cancer Center
  • Catholic University of the Sacred Heart
  • Erasme University Hospital
Investigators  ICMJE
Principal Investigator: Michael B Wallace, M.D. Mayo Clinic
PRS Account Olympus Corporation
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP