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Spectroscopy From Duodenum

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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

Study Description
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Brief Summary:
Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Other: Spectroscopy device Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Belgium
Hôpital Erasme
Bruxelles, Brussels-Capital Region, Belgium, 1070
Italy
Università Cattolica del Sacro Cuore
Rome, Lazio, Italy, 00168
Sponsors and Collaborators
Olympus Corporation
M.D. Anderson Cancer Center
Catholic University of the Sacred Heart
Erasme University Hospital
Investigators
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Principal Investigator: Michael B Wallace, M.D. Mayo Clinic
More Information
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Responsible Party: Olympus Corporation
ClinicalTrials.gov Identifier: NCT01753479    
Other Study ID Numbers: OMSC-Mag-1
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Keywords provided by Olympus Corporation:
Pancreatic adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms