Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT (HYPHYCA)

January 10, 2019 updated by: Centre Francois Baclesse
Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

644

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Caen, France, 14000
        • CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient coming for a PET

Description

Inclusion Criteria:

  • Patient 18 years old
  • Patient referred for 18F-FDG PET

Exclusion Criteria:

  • History of surgery or anal and / or perineal and / or pelvic radiotherapy, whatever the indication
  • Patient deprived of liberty, under tutorship or curatorship
  • Any associated socio-educational, medical or psychological condition that could compromise the patient's ability to participate in the study (eg illiteracy, mental retardation, etc.)
  • Pregnant woman (classic contraindication of a PET scan)
  • Opposition of the patient to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of predictive factors for physiological hypermetabolism of the anal canal in 18F-FDG PET / CT
Time Frame: Only at the day of inclusion, during an appointment for a TEP exam

Confrontation in participants of hypermetabolism of the anal canal in PET with:

number of stool/day and consistency of stool, medical history (by Answers to the specific questionnaire designed for the study)
Only at the day of inclusion, during an appointment for a TEP exam
PET analysis of hypermetabolism of the anal canal
Time Frame: Only at the day of inclusion, during an appointment for a TEP exam

Visual analysis of hypermetabolism of the anal canal on a 3-point scale:

0: no hypermetabolism

  1. moderate hypermetabolism
  2. intense hypermetabolism
Only at the day of inclusion, during an appointment for a TEP exam
CT scan with measurement
Time Frame: Only at the day of inclusion, during an appointment for a TEP exam
measurement of the largest rectal diameter in mm.
Only at the day of inclusion, during an appointment for a TEP exam
CT scan with measurement
Time Frame: Only at the day of inclusion, during an appointment for a TEP exam
Visual assessment of the rectal capacity on a 3-point scale (0, 1, 2) and content characteristics (air, feces, air and feces).
Only at the day of inclusion, during an appointment for a TEP exam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 17, 2018

Primary Completion (ACTUAL)

November 15, 2018

Study Completion (ACTUAL)

November 15, 2018

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (ACTUAL)

April 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A03545-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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