Colon CancerNCT00188110
Performance of the Water-Enema Computed Tomography (WE-CT)
A study testing Water-Enema Computed Tomography in people with Colon Cancer, run by University Hospital, Angers at 5 sites in France.
Trial summary
The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Water-Enema Computed Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2003to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- WE-TC indication for colon tumor suspicion
- Age > 18 years
Who cannot join
- Pregnancy
- Patients under 65 years old and for whom the only WE-TC indication is familial antecedents of colon tumor, without clinical or para-clinical personal signs for this pathology
- Infected sigmoid diverticulosis
- Occlusive syndrome
- Anesthesia contraindications
- Anal incontinence
Show all 10Show fewer
- Renal insufficiency (creatinine > 150 micromol/L)
- Iode allergy
- Visceralgine contraindications
- Scania contraindications
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 3 recruiting
- Recruiting
UH of Angers
Angers, 49033
Christophe Aube, MD, 00-2-41-35-42-76, chaube@chu-angers.fr
Christophe Aube, MD
- Active, not recruiting
UH of Besancon
Besançon, 25030
- Recruiting
UH of Lyon
Lyon, 69003
Jean Valette, MD, 00-4-72-11-75-40, jean.valette@chu-lyon.fr
Pierre Jean Valette, MD
- Active, not recruiting
UH of Montpellier
Montpellier, 34295
- Recruiting
UH of Rennes
Rennes, 35033
Yves Gandon, MD, 00-2-99-28-43-67, yves-gandon@chu-rennes.fr
Yves Gandon, MD
About this study
Official title: Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor
The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.
The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.
- Conditions
- Colon Cancer
- Being tested
- Water-Enema Computed Tomography
- Keywords
- Water-Enema Computed Tomography, colon tumor, coloscopy, suspicion of colon tumor, coloscopy or surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-Enema Computed TomographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performances of the WE-CT in patients suspected of having a colon tumor
Secondary outcomes (2)
To show the CT findings in case of colon tumor and its pitfalls
To demonstrate the advantages of the WE-CT compared to the CT and magnetic resonance (MR) colonography for the diagnosis and local staging of colon tumors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, France
- Investigators
- Christophe Aube, MD, Principal investigator, UH of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188110
- Sponsor's protocol ID
- PHRC-02-01
- Other IDs
- 2002/23 (CCPPRB)
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 9 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor
- ClinicalTrials.gov ID
- NCT00188110
- Acronym / sponsor ID
- PHRC-02-01
- Conditions
- Colon Cancer
- Keywords
- Water-Enema Computed Tomography, colon tumor, coloscopy, suspicion of colon tumor, coloscopy or surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2003
- First posted
- 16 Sep 2005 (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 WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.
The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- WE-TC indication for colon tumor suspicion
- Age > 18 years
Key exclusion criteria (10 listed)
- Pregnancy
- Patients under 65 years old and for whom the only WE-TC indication is familial antecedents of colon tumor, without clinical or para-clinical personal signs for this pathology
- Infected sigmoid diverticulosis
- Occlusive syndrome
- Anesthesia contraindications
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 |
|---|---|---|
| Water-Enema Computed Tomography | Procedure or surgery | – |
Primary outcome
To evaluate the performances of the WE-CT in patients suspected of having a colon tumor
2 secondary outcomes
To show the CT findings in case of colon tumor and its pitfalls
To demonstrate the advantages of the WE-CT compared to the CT and magnetic resonance (MR) colonography for the diagnosis and local staging of colon tumors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2007.
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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.
Christophe Aube, MD principal investigator
UH of Angers
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-Enema Computed Tomography in people with Colon Cancer, run by University Hospital, Angers at 5 sites in France.
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 3 inclusion and 10 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 9 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 Christophe Aube, MD (00-2-41-35-42-76, chaube@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the performances of the WE-CT in patients suspected of having a colon tumor. 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 9 Jan 2007.