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Spectroscopy From Duodenum

Primary Purpose

Pancreatic Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spectroscopy device
Sponsored by
Olympus Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Adenocarcinoma focused on measuring Pancreatic adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Florida
  • The University of Texas M. D. Anderson Cancer Center
  • Hôpital Erasme
  • Università Cattolica del Sacro Cuore

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test subject

Arm Description

Outcomes

Primary Outcome Measures

The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort
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.
A receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.

Full Information

First Posted
December 17, 2012
Last Updated
March 3, 2017
Sponsor
Olympus Corporation
Collaborators
M.D. Anderson Cancer Center, Catholic University of the Sacred Heart, Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01753479
Brief Title
Spectroscopy From Duodenum
Official Title
Duodenal Spectroscopy Study for Cancer Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympus Corporation
Collaborators
M.D. Anderson Cancer Center, Catholic University of the Sacred Heart, Erasme University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
Pancreatic adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test subject
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Spectroscopy device
Intervention Description
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.
Primary Outcome Measure Information:
Title
The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort
Description
To clarify that there is the statistically-significant difference between two cohorts.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants.
Description
A receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Wallace, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
The University of Texas M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hôpital Erasme
City
Bruxelles
State/Province
Brussels-Capital Region
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Università Cattolica del Sacro Cuore
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Spectroscopy From Duodenum

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