Anal CarcinomaNCT03469596
Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?
An observational study of Anal Carcinoma, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Anal canal cell carcinoma is a very rare cancer but well treated. If the morphological test are well established in the initial evaluation, it's not the case of the follow up evaluation particularly by MRI.About 1/3 of patient decline with metastatic relapse during the follow up of these patients.It appears that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Carcinoma
- What is being tested?
- MRI sequence
- Type of treatment
- Injection or infusion
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 31 Dec 2017
- Phase
- Observational
- 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
Study population: every patient with anal canal cell carcinoma with an initial MRI in GHPS between 1st august 2009 and 24th april of 2015
Who may be able to join
- patient with anal canal cell carcinoma histologically proved
- patient with initial MRI and follow up MRI in Hospital St Joseph's radiology yard.
- patient for whom a radio chemotherapy treatment decision was taken.
Who cannot join
- patients with already metastatic lesions
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Anal canal cell carcinoma is a very rare cancer but well treated. If the morphological test are well established in the initial evaluation, it's not the case of the follow up evaluation particularly by MRI.About 1/3 of patient decline with metastatic relapse during the follow up of these patients.It appears that clinical regression seen precociously is a predictive factor of survival without relapse. But there 's no study confirming that point.
This context takes us to evaluate if there is a predictive factor in MRI to final clinical result.
- Conditions
- Anal Carcinoma
- Being tested
- MRI sequence
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI sequenceDiagnostic test
several MRI sequence before and after contrast product injection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance with regard to the anal margin
tumor position
Measured: maximum of 6 years after the initial MRI
initial tumor size
Maximal tumoral size in the cranio-caudal plan in cm
Measured: maximum of 6 years after the initial MRI
presence of nodal status
presence of nodal status in inguinal region
Measured: maximum of 6 years after the initial MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Apr 2017
- Primary completion1 May 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469596
- Sponsor's protocol ID
- IRMcanalANAL
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?
- ClinicalTrials.gov ID
- NCT03469596
- Acronym / sponsor ID
- IRMcanalANAL
- Conditions
- Anal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Mar 2018 (actual)
- 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.
Anal canal cell carcinoma is a very rare cancer but well treated. If the morphological test are well established in the initial evaluation, it's not the case of the follow up evaluation particularly by MRI.About 1/3 of patient decline with metastatic relapse during the follow up of these patients.It appears that clinical regression seen precociously is a predictive factor of survival without relapse. But there 's no study confirming that point.
This context takes us to evaluate if there is a predictive factor in MRI to final clinical result.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- every patient with anal canal cell carcinoma with an initial MRI in GHPS between 1st august 2009 and 24th april of 2015
Key inclusion criteria (3 listed)
- patient with anal canal cell carcinoma histologically proved
- patient with initial MRI and follow up MRI in Hospital St Joseph's radiology yard.
- patient for whom a radio chemotherapy treatment decision was taken.
Key exclusion criteria (1 listed)
- patients with already metastatic lesions
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 |
|---|---|---|
| MRI sequenceseveral MRI sequence before and after contrast product injection. | Diagnostic test | – |
Primary outcome
Distance with regard to the anal margin
Time frame: maximum of 6 years after the initial MRI
tumor position
initial tumor size
Time frame: maximum of 6 years after the initial MRI
Maximal tumoral size in the cranio-caudal plan in cm
presence of nodal status
Time frame: maximum of 6 years after the initial MRI
presence of nodal status in inguinal region
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 22 Mar 2018.
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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?
An observational study of Anal Carcinoma, run by Fondation Hôpital Saint-Joseph at 1 site 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 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 22 Mar 2018. 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 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?
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?
Distance with regard to the anal margin (time frame: maximum of 6 years after the initial MRI). The study lists 3 primary outcomes in all. 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 22 Mar 2018.