Spectroscopy From Duodenum

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Olympus Medical Systems Corporation
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Catholic University of the Sacred Heart
Erasme University Hospital
Information provided by (Responsible Party):
Olympus Medical Systems Corporation
ClinicalTrials.gov Identifier:
NCT01753479
First received: December 17, 2012
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.


Condition Intervention
Pancreatic Adenocarcinoma
Other: Spectroscopy device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Duodenal Spectroscopy Study for Cancer Diagnosis

Further study details as provided by Olympus Medical Systems Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753479

Contacts
Contact: Michael B Wallace, M.D. (904)953-7382 Wallace.Michael@mayo.edu

Locations
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
Belgium
Hôpital Erasme Recruiting
Bruxelles, Brussels-Capital Region, Belgium, 1070
Italy
Università Cattolica del Sacro Cuore Recruiting
Rome, Lazio, Italy, 00168
Sponsors and Collaborators
Olympus Medical Systems Corporation
M.D. Anderson Cancer Center
Catholic University of the Sacred Heart
Erasme University Hospital
Investigators
Principal Investigator: Michael B Wallace, M.D. Mayo Clinic Florida
  More Information

No publications provided

Responsible Party: Olympus Medical Systems Corporation
ClinicalTrials.gov Identifier: NCT01753479     History of Changes
Other Study ID Numbers: OMSC-Mag-1
Study First Received: December 17, 2012
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Olympus Medical Systems Corporation:
Pancreatic adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014