Evaluation by MRI of Anal Canal Cell Carcinoma: is There... | NCT03469596

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

NCT03469596

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Mar 22, 2018Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Anal Carcinoma

Interventions

MRI sequence

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

May 1, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Mar 12, 2018

First Submission Date that Met QC Criteria

Mar 16, 2018

First Posted Date

Mar 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2018

Last Update Posted Date

Mar 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI sequence	Diagnostic Test	several MRI sequence before and after contrast product injection.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D001005	Anus Neoplasms

Ancestor Terms

ID	Term
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided