ClinicalTrials.gov

History of Changes for Study: NCT03506529
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT (HYPHYCA)
Latest version (submitted January 10, 2019) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 23, 2018 None (earliest Version on record)
2 January 10, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT03506529
Submitted Date:  April 23, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2017-A03545-48
Brief Title: Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT (HYPHYCA)
Official Title: Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2018
Overall Status: Recruiting
Study Start: April 12, 2018
Primary Completion: September 2018 [Anticipated]
Study Completion: September 2018 [Anticipated]
First Submitted: April 12, 2018
First Submitted that
Met QC Criteria:
April 23, 2018
First Posted: April 24, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
April 23, 2018
Last Update Posted: April 24, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Centre Francois Baclesse
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal
Detailed Description:
Open or close this module Conditions
Conditions: Anal Cancer
Keywords: TEP
hypermetabolism
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 400 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
questionnary
questionnary on predictif factors about physiological hypermetabolism of anal canal
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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)

2. 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
3. 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.
4. 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).
Open or close this module Eligibility
Study Population: Any patient coming for a PET
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Charline LASNON, MD
Telephone: 0231455050
Email: c.lasnon@baclesse.unicancer.fr
Locations: France
CHU
[Recruiting]
Caen, France, 14000
Contact:Contact: Nicolas AIDE, Prof
Centre Fran├žois Baclesse
[Recruiting]
Caen, France, 14076
Contact:Contact: Charline LASNON, MD
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services