Spectroscopy From Duodenum

Duodenal Spectroscopy Study for Cancer Diagnosis

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Other: Spectroscopy device

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: Interventional
• Enrollment (Actual): 445
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels-Capital Region
    • Bruxelles, Brussels-Capital Region, Belgium, 1070
      • Hôpital Erasme
• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Universita Cattolica del Sacro Cuore
• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas M. D. Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Olympus Corporation
• Collaborators: M.D. Anderson Cancer Center; Catholic University of the Sacred Heart; Erasme University Hospital
• Investigators: Principal Investigator: Michael B Wallace, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Pancreatic adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: OMSC-Mag-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No