Colorectal Cancer Detection by Means of Optical Fluoroscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01286064
First received: January 27, 2011
Last updated: January 28, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention
Colorectal Cancer
Device: Optical Fluoroscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Official Title: Role of Natural Fluorescence of Human Blood Plasma in Patients With Colorectal Cancer.

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • Colorectal cancer detection by means of optical fluoroscopy [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patient with colo-rectal cancer
fluorescence spectra will be mainly characterized by the presence of an emission peaking at 620-630 nm
Device: Optical Fluoroscopy
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).
Active Comparator: patient without colo-rectal cancer
fluorescence spectra will be characterized by the absence of an emission peaking at 620-630 nm
Device: Optical Fluoroscopy
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01286064

Contacts
Contact: vannelli alberto, MD 00390223902044 alberto.vannelli@istitutotumori.mi.it

Locations
Italy
Fondazione IRCCS Istituto Nazionale Tumori Recruiting
Milan, Italy, 20133
Contact: Alberto vannelli, MD    00390223902044    alberto.vannelli@istitutotumori.mi.it   
Contact: Ermanno Leo, MD    00390223902616    ermanno.leo@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Study Director: alberto vannelli, md Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  More Information

Additional Information:
No publications provided

Responsible Party: Alberto Vannelli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01286064     History of Changes
Other Study ID Numbers: INT-D178768
Study First Received: January 27, 2011
Last Updated: January 28, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
adenocarcinoma,
colorectal tumors,
endogenous porphyrins,
fluorescence,
tumor markers.

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014