Colorectal CancerNCT01286064
Colorectal Cancer Detection by Means of Optical Fluoroscopy
A study testing Optical Fluoroscopy in people with Colorectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Optical Fluoroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gastrointestinal disease clinical symptoms related to colorectal cancer risk endoscopy
Who cannot join
- Age younger than 18 years or more than 75 years, history of psychiatric illness, preoperative chemo/radiotherapy.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy, 20133
Alberto vannelli, MD, 00390223902044, alberto.vannelli@istitutotumori.mi.it
Ermanno Leo, MD, 00390223902616, ermanno.leo@istitutotumori.mi.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Optical Fluoroscopy
- Keywords
- adenocarcinoma,, colorectal tumors,, endogenous porphyrins,, fluorescence,, tumor markers.
- Medical subject headings
- Colorectal Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical FluoroscopyDevice
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).
Optical FluoroscopyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| patient with colo-rectal cancer | Experimental | fluorescence spectra will be mainly characterized by the presence of an emission peaking at 620-630 nm Receives: Device: Optical Fluoroscopy |
| patient without colo-rectal cancer | Active comparator | fluorescence spectra will be characterized by the absence of an emission peaking at 620-630 nm Receives: Device: Optical Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- alberto vannelli, md, Study director, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286064
- Sponsor's protocol ID
- INT-D178768
- Status last verified
- Sep 2010
- First submitted
- 27 Jan 2011
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Natural Fluorescence of Human Blood Plasma in Patients With Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT01286064
- Acronym / sponsor ID
- INT-D178768
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma,, colorectal tumors,, endogenous porphyrins,, fluorescence,, tumor markers.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (estimated)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with colo-rectal cancer | Experimental | Device: Optical Fluoroscopyfluorescence spectra will be mainly characterized by the presence of an emission peaking at 620-630 nm |
| patient without colo-rectal cancer | Active comparator | Device: Optical Fluoroscopyfluorescence spectra will be characterized by the absence of an emission peaking at 620-630 nm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gastrointestinal disease clinical symptoms related to colorectal cancer risk endoscopy
Key exclusion criteria (1 listed)
- Age younger than 18 years or more than 75 years, history of psychiatric illness, preoperative chemo/radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical FluoroscopyLithium-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). | Device | patient with colo-rectal cancer |
| Optical FluoroscopyLithium-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). | Device | patient without colo-rectal cancer |
Primary outcome
Colorectal cancer detection by means of optical fluoroscopy
Time frame: 18 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2011.
- Fondazione IRCCS Istituto Nazionale Tumori, Milan, ItalyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alberto vannelli, md study director
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Fluoroscopy in people with Colorectal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact vannelli alberto, MD (00390223902044, alberto.vannelli@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer detection by means of optical fluoroscopy (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2011.