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

Anal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469596
• Other study ID #: IRMcanalANAL
• Status: Completed
• First received: March 12, 2018
• Last updated: March 21, 2018
• Start date: April 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 31, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Carcinoma
• Anus Neoplasms
• Carcinoma

Intervention

Diagnostic Test:
• MRI sequence
several MRI sequence before and after contrast product injection.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

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