Spectroscopy From Duodenum

Pancreatic Adenocarcinoma Clinical Trial

Official title:

Duodenal Spectroscopy Study for Cancer Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753479
• Other study ID #: OMSC-Mag-1
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: March 3, 2017
• Start date: January 2013
• Est. completion date: June 30, 2016

Study information

• Verified date: March 2017
• Source: Olympus Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Bruxelles	Brussels-Capital Region
Italy	Università Cattolica del Sacro Cuore	Rome	Lazio
United States	The University of Texas M. D. Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Olympus Corporation	Catholic University of the Sacred Heart, Erasme University Hospital, M.D. Anderson Cancer Center

Countries where clinical trial is conducted

United States,  Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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