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CompletedNCT03469596Updated Mar 22, 2018

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

An observational study in Anal Carcinoma, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-22.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
87
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anal Carcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  • patients with already metastatic lesions
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
87 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testMRI sequence

    several MRI sequence before and after contrast product injection.

05

What researchers measure

Primary outcomes

  1. Distance with regard to the anal margin

    tumor position

    Time frame: maximum of 6 years after the initial MRI

  2. initial tumor size

    Maximal tumoral size in the cranio-caudal plan in cm

    Time frame: maximum of 6 years after the initial MRI

  3. presence of nodal status

    presence of nodal status in inguinal region

    Time frame: maximum of 6 years after the initial MRI

06

Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile-de-France 75014, France
07

Registry details

Key details

Study ID
NCT03469596
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
Mar 19, 2018
Start date
Apr 1, 2017
Primary completion
May 1, 2017
Completion
Dec 31, 2017
Last update
Mar 22, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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