Clinical trial NCT01286064: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: adenocarcinoma,
colorectal tumors,
endogenous porphyrins,
fluorescence,
tumor markers.
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Colorectal cancer detection by means of optical fluoroscopy
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: alberto vannelli, md
role: STUDY_DIRECTOR
References: