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

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT03469596
Collaborator
(none)
87
Enrollment
1
Location
9
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI sequence

Study Design

Study Type:
Observational
Actual Enrollment :
87 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?
Actual Study Start Date :
Apr 1, 2017
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Dec 31, 2017

Outcome Measures

Primary Outcome Measures

  1. Distance with regard to the anal margin [maximum of 6 years after the initial MRI]

    tumor position

  2. initial tumor size [maximum of 6 years after the initial MRI]

    Maximal tumoral size in the cranio-caudal plan in cm

  3. presence of nodal status [maximum of 6 years after the initial MRI]

    presence of nodal status in inguinal region

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France France 75014

Sponsors and Collaborators

  • Groupe Hospitalier Paris Saint Joseph

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT03469596
Other Study ID Numbers:
  • IRMcanalANAL
First Posted:
Mar 19, 2018
Last Update Posted:
Mar 22, 2018
Last Verified:
Mar 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Anus Neoplasms

Study Results

No Results Posted as of Mar 22, 2018