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

January 27, 2011
January 28, 2011
October 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01286064 on ClinicalTrials.gov Archive Site
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Colorectal Cancer Detection by Means of Optical Fluoroscopy
Role of Natural Fluorescence of Human Blood Plasma in Patients With Colorectal Cancer.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Colorectal Cancer
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).
  • Experimental: patient with colo-rectal cancer
    fluorescence spectra will be mainly characterized by the presence of an emission peaking at 620-630 nm
    Intervention: Device: Optical Fluoroscopy
  • Active Comparator: patient without colo-rectal cancer
    fluorescence spectra will be characterized by the absence of an emission peaking at 620-630 nm
    Intervention: Device: Optical Fluoroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
April 2011
December 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
Yes
Contact: vannelli alberto, MD 00390223902044 alberto.vannelli@istitutotumori.mi.it
Italy
 
NCT01286064
INT-D178768
Yes
Alberto Vannelli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Not Provided
Study Director: alberto vannelli, md Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP