Spectroscopy From Duodenum

Not Applicable

Completed

• Conditions: Pancreatic Adenocarcinoma
• Interventions: Other: Spectroscopy device

• Registration Number: NCT01753479
• Lead Sponsor: Olympus Corporation

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 Timeline

• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Study Start: 2013-01
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test subject	Spectroscopy device	-

Primary Outcome Measures

Name	Time	Method
The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort	1 year	To clarify that there is the statistically-significant difference between two cohorts.

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants.	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.

Trial Locations

Locations (4)

The University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Hôpital Erasme; 🇧🇪 Bruxelles, Brussels-Capital Region, Belgium

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Università Cattolica del Sacro Cuore; 🇮🇹 Rome, Lazio, Italy