Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?

March 21, 2018 updated by: Groupe Hospitalier Paris Saint Joseph

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

every patient with anal canal cell carcinoma with an initial MRI in GHPS between 1st august 2009 and 24th april of 2015

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • patients with already metastatic lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance with regard to the anal margin
Time Frame: maximum of 6 years after the initial MRI
tumor position
maximum of 6 years after the initial MRI
initial tumor size
Time Frame: maximum of 6 years after the initial MRI
Maximal tumoral size in the cranio-caudal plan in cm
maximum of 6 years after the initial MRI
presence of nodal status
Time Frame: maximum of 6 years after the initial MRI
presence of nodal status in inguinal region
maximum of 6 years after the initial MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRMcanalANAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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