NCT03469596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1 month

First QC Date

March 12, 2018

Last Update Submit

March 21, 2018

Conditions

Anal Carcinoma

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

MRI sequenceDIAGNOSTIC_TEST

several MRI sequence before and after contrast product injection.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • patients with already metastatic lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 19, 2018

Study Start

April 1, 2017

Primary Completion

May 1, 2017

Study Completion

December 31, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

FR(1)