Rectal CancerNCT00963794
Diagnosis of Rectal Cancer by Electromagnetic Device
A study testing Electromagnetic measurement in people with Rectal 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 evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Electromagnetic measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Dec 2008
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastrointestinal disease or clinical symptoms related to colorectal cancer risk.
Who cannot join
- Age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation on a Device for the Diagnosis of Rectal Cancer
The aim of the present prospective study was to evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal < 50 units (U).
Read the detailed description
Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe (TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. No metallic objects were allowed on the patient and no electronic devices were admitted in the test area. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on the investigators previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the anal verge.
- Conditions
- Rectal Cancer
- Being tested
- Electromagnetic measurement
- Keywords
- Rectal cancer, Population screening, Early detection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic measurementOther
Also called TrimProb
RC screening was carried out using a Tissue Resonance InterferoMeter probe electromagnetic detector, which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on our previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic measurement | Other | Electromagnetic measurement to detect rectal cancer. Receives: Other: Electromagnetic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963794
- Sponsor's protocol ID
- INT-D176767
- Status last verified
- Aug 2009
- First submitted
- 20 Aug 2009
- Last updated
- 24 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation on a Device for the Diagnosis of Rectal Cancer
- ClinicalTrials.gov ID
- NCT00963794
- Acronym / sponsor ID
- INT-D176767
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Population screening, Early detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Aug 2009 (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 evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal < 50 units (U).
Detailed description
Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe (TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. No metallic objects were allowed on the patient and no electronic devices were admitted in the test area. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on the investigators previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the anal verge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic measurement | Other | Other: Electromagnetic measurementElectromagnetic measurement to detect rectal cancer. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gastrointestinal disease or clinical symptoms related to colorectal cancer risk.
Key exclusion criteria (1 listed)
- Age younger than 18 years, history of psychiatric illness, and preoperative 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 |
|---|---|---|
| Electromagnetic measurementAlso: TrimProbRC screening was carried out using a Tissue Resonance InterferoMeter probe electromagnetic detector, which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on our previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. | Other | Electromagnetic measurement |
Primary outcome
Electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2009.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic measurement in people with Rectal 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: finished, as of the sponsor's last update on 24 Aug 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. (time frame: 6 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 24 Aug 2009.