NCT01753479

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
445

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

3.5 years

First QC Date

December 17, 2012

Last Update Submit

March 3, 2017

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 year

Study Arms (1)

Test subject

EXPERIMENTAL
Other: Spectroscopy device

Interventions

Spectroscopy deviceOTHER

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.

Test subject

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age is 18 years or older.
  • Informed consent was obtained.
  • An upper GI endoscopy is scheduled to check upper abdominal symptoms.
  • No findings of pancreatic disorder as documented by CT or MRI or EUS

You may not qualify if:

  • Severe cardiac disease
  • Severe respiratory disease
  • Bleeding disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hôpital Erasme

Brussels, Brussels Capital, 1070, Belgium

Location

Università Cattolica del Sacro Cuore

Rome, Lazio, 00168, Italy

Location

Study Officials

  • Michael B Wallace, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

January 1, 2013

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

IT(1)US(2)BE(1)