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Colorectal Cancer Detection by Means of Optical Fluoroscopy

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Optical Fluoroscopy
Optical Fluoroscopy
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring adenocarcinoma,, colorectal tumors,, endogenous porphyrins,, fluorescence,, tumor markers.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Gastrointestinal disease clinical symptoms related to colorectal cancer risk endoscopy

Exclusion Criteria:

Age younger than 18 years or more than 75 years, history of psychiatric illness, preoperative chemo/radiotherapy.

Sites / Locations

  • Fondazione IRCCS Istituto Nazionale TumoriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patient with colo-rectal cancer

patient without colo-rectal cancer

Arm Description

fluorescence spectra will be mainly characterized by the presence of an emission peaking at 620-630 nm

fluorescence spectra will be characterized by the absence of an emission peaking at 620-630 nm

Outcomes

Primary Outcome Measures

Colorectal cancer detection by means of optical fluoroscopy
investigated the possible role of the native fluorescence of blood plasma in the management of colorectal cancer (CRC) and its feasibility as a new tumor marker.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2011
Last Updated
January 28, 2011
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT01286064
Brief Title
Colorectal Cancer Detection by Means of Optical Fluoroscopy
Official Title
Role of Natural Fluorescence of Human Blood Plasma in Patients With Colorectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present prospective study was to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For years, serum tumor markers have been studied for the diagnosis and follow-up of colorectal cancer, among which carcinoembryonic antigen (CEA) has achieved promising results. However, the sensitivity of CEA for colorectal cancer is less than 25% and elevated CEA levels also occur in patients with benign disease, as well as in patients with other carcinomas. Nevertheless, surveillance programs are often based on the CEA test and combination with other markers is at present a matter of research. Alternative methods based on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of cancer. Few studies have been reported on the application of native fluorescence spectroscopy of biofluids in the diagnosis of tumoral diseases. The above reported findings prompted us to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For this purpose, the blood of patients was collected and the fluorescence Preliminary measurements on plasma of patients bearing colon cancer showed that the fluorescence spectra were mainly characterized by the presence of an emission peaking at 620-630 nm, whose excitation spectrum peaked at 405 nm. Hence, an excitation wavelength of 405 nm was selected for the study. The fluorescence emission spectra were recorded in the range of 430-700 nm.
Detailed Description
Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk submitted to endoscopy. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy. Outcome: investigated the possible role of the native fluorescence of blood plasma in the management of colorectal cancer (CRC) and its feasibility as a new tumor marker. Sample of blood was collected from asymptomatic blood donors and from CRC patients. The native fluorescence of blood plasma was measured using a conventional spectrofluorimeter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
adenocarcinoma,, colorectal tumors,, endogenous porphyrins,, fluorescence,, tumor markers.

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient with colo-rectal cancer
Arm Type
Experimental
Arm Description
fluorescence spectra will be mainly characterized by the presence of an emission peaking at 620-630 nm
Arm Title
patient without colo-rectal cancer
Arm Type
Active Comparator
Arm Description
fluorescence spectra will be characterized by the absence of an emission peaking at 620-630 nm
Intervention Type
Device
Intervention Name(s)
Optical Fluoroscopy
Intervention Description
Lithium-heparin was added to the blood samples to prevent coagulation. The samples were then centrifuged and the plasma was removed without disturbing the buffy coat and the erythrocyte sediments. The separated changes in the enzyme associated with heme biosynthesis have been reported for peripheral mononuclear cells in patients with epithelial tumors and metastatic spread. plasma was stored at -20 °C until assayed. For fluorescence measurements, analytical grade acetone was added to plasma in a 1:1 ratio by volume and the mixture was centrifuged. The clear supernatant was placed in a quartz cuvette of 1 cm path length for further analysis. Fluorescence analysis of blood plasma was performed by means of a spectrofluorometer (Model F-3000, Hitachi, Ltd., Tokyo, Japan).
Intervention Type
Device
Intervention Name(s)
Optical Fluoroscopy
Intervention Description
Lithium-heparin was added to the blood samples to prevent coagulation. The samples were then centrifuged and the plasma was removed without disturbing the buffy coat and the erythrocyte sediments. The separated changes in the enzyme associated with heme biosynthesis have been reported for peripheral mononuclear cells in patients with epithelial tumors and metastatic spread. plasma was stored at -20 °C until assayed. For fluorescence measurements, analytical grade acetone was added to plasma in a 1:1 ratio by volume and the mixture was centrifuged. The clear supernatant was placed in a quartz cuvette of 1 cm path length for further analysis. Fluorescence analysis of blood plasma was performed by means of a spectrofluorometer (Model F-3000, Hitachi, Ltd., Tokyo, Japan).
Primary Outcome Measure Information:
Title
Colorectal cancer detection by means of optical fluoroscopy
Description
investigated the possible role of the native fluorescence of blood plasma in the management of colorectal cancer (CRC) and its feasibility as a new tumor marker.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gastrointestinal disease clinical symptoms related to colorectal cancer risk endoscopy Exclusion Criteria: Age younger than 18 years or more than 75 years, history of psychiatric illness, preoperative chemo/radiotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
vannelli alberto, MD
Phone
00390223902044
Email
alberto.vannelli@istitutotumori.mi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alberto vannelli, md
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto vannelli, MD
Phone
00390223902044
Email
alberto.vannelli@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Ermanno Leo, MD
Phone
00390223902616
Email
ermanno.leo@istitutotumori.mi.it

12. IPD Sharing Statement

Links:
URL
http://www.istitutotumori.mi.it/
Description
Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

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Colorectal Cancer Detection by Means of Optical Fluoroscopy

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