Colorectal Cancer Detection by Means of Optical Fluoroscopy
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 27, 2011 | ||||
| Last Updated Date | January 28, 2011 | ||||
| Start Date ICMJE | October 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01286064 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Colorectal Cancer Detection by Means of Optical Fluoroscopy | ||||
| Official Title ICMJE | Role of Natural Fluorescence of Human Blood Plasma in Patients With Colorectal Cancer. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Screening |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | 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). |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | April 2011 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01286064 | ||||
| Other Study ID Numbers ICMJE | INT-D178768 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Alberto Vannelli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | ||||
| Study Sponsor ICMJE | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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