Anal CancerHYPHYCANCT03506529
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
An observational study of Anal Cancer, run by Centre Francois Baclesse at 2 sites in France.
Trial summary
Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- questionnary
- How many people
- 644 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Sep 2018to 15 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient coming for a PET
Who may be able to join
- Patient 18 years old
- Patient referred for 18F-FDG PET
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal
- Conditions
- Anal Cancer
- Being tested
- questionnary
- Keywords
- TEP, hypermetabolism
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaryOther
questionnary on predictif factors about physiological hypermetabolism of anal canal
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of predictive factors for physiological hypermetabolism of the anal canal in 18F-FDG PET / CT
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)
Measured: Only at the day of inclusion, during an appointment for a TEP exam
PET analysis of hypermetabolism of the anal canal
Visual analysis of hypermetabolism of the anal canal on a 3-point scale:
0: no hypermetabolism
- moderate hypermetabolism
- intense hypermetabolism
Measured: Only at the day of inclusion, during an appointment for a TEP exam
CT scan with measurement
measurement of the largest rectal diameter in mm.
Measured: Only at the day of inclusion, during an appointment for a TEP exam
CT scan with measurement
Visual assessment of the rectal capacity on a 3-point scale (0, 1, 2) and content characteristics (air, feces, air and feces).
Measured: Only at the day of inclusion, during an appointment for a TEP exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start17 Sep 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506529
- Sponsor's protocol ID
- 2017-A03545-48
- Acronym
- HYPHYCA
- Status last verified
- Jan 2019
- First submitted
- 12 Apr 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aide N, Tainturier LE, Nganoa C, Houdu B, Kammerer J, Galais MP, Ciappuccini R, Lasnon C. HYPHYCA: a prospective study in 613 patients conducting a comprehensive analysis for predictive factors of physiological 18F-FDG anal uptake. EJNMMI Res. 2020 Mar 20;10(1):28. doi: 10.1186/s13550-020-0615-5.
PubMed 32193623
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
- ClinicalTrials.gov ID
- NCT03506529
- Acronym / sponsor ID
- HYPHYCA / 2017-A03545-48
- Conditions
- Anal Cancer
- Keywords
- TEP, hypermetabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient coming for a PET
Key inclusion criteria (2 listed)
- Patient 18 years old
- Patient referred for 18F-FDG PET
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaryquestionnary on predictif factors about physiological hypermetabolism of anal canal | Other | – |
Primary outcome
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)
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
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 32193623Aide N, Tainturier LE, Nganoa C, Houdu B, Kammerer J, Galais MP, Ciappuccini R, Lasnon C. HYPHYCA: a prospective study in 613 patients conducting a comprehensive analysis for predictive factors of physiological 18F-FDG anal uptake. EJNMMI Res. 2020 Mar 20;10(1):28. doi: 10.1186/s13550-020-0615-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by Centre Francois Baclesse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.