Anal CancerIFACTNCT02697084
Individual Following in Anal Cancer With PET/CT
An observational study of Anal Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6% of anorectal cancers. Incidence is less than 1/100 000 of the general population. However, the incidence has increased considerably over the past three decades. The main risk factors are HPV infections and smoking. 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?
- anal cancer
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Sep 2024
- 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: Canal anal cancer
Who may be able to join
- Consecutive inclusion of incident cases of anal canal cancer between November 2014 and May 2018. These patients are volunteers and have signed informed consent.
Who cannot join
- Presence of a nother cancer and specific treatment (chemotherapy, radiotherapy). Follow-up impossible during two years or more.
- Refusal to submit to initial or post-treatment PET/CT.
Trial locations and contacts
1 site in 1 country.
About this study
Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6% of anorectal cancers. Incidence is less than 1/100 000 of the general population. However, the incidence has increased considerably over the past three decades. The main risk factors are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of the most appropriate treatment strategy will condition the patient's prognosis. Consequently, early assessment of the initial extension of the tumor, its therapeutic response and relapses constitute determining factors in the management of the disease Despite the good results obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage amputation can then prove effective in cases of local or loco-regional relapse. The great majority of relapses occur within 2 years after treatment. Reported prognostic survival factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node involvement.
The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses principally on the clinical examination although the type and frequency of the paraclinical examinations are not backed by any consensus.
Read the detailed description
Post-treatment 18-FDG PET scan at 2 months can prove useful to predict locoregional or metastatic recurrence in patients treated by radiochemotherapy or radiotherapy in the anal canal cancer setting. There appear to be an FDG intensity variable and a metabolic response criterion enabling establishment of two groups of patients: low recurrence risk versus high recurrence risk at 2 years.
- Conditions
- Anal Cancer
- Being tested
- anal cancer
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anal cancerOther
Anal cancer patients with TEP TDM
What is being measured
The primary outcome is the main question the study is designed to answer.
time of disease-free survival
Measured: 3 years
Secondary outcomes (8)
best metabolic response measurement variable: SUVmax
Measured: 3 years
best metabolic response measurement variable: SUVmean
Measured: 3 years
best metabolic response measurement variable: SUL peak
Measured: 3 years
best metabolic response measurement variable: Metabolic Total Volume (MTV)
Measured: 3 years
best metabolic response measurement variable: Total Lesion Glycolysis (TLG)
Measured: 3 years
best treatment response criterion: SUV or metabolic volume threshold
Measured: 3 years
best treatment response criterion: ratio (SUV or metabolic volume)
Measured: 3 years
best treatment response criterion: complete or partial metabolic response according to EORTC or PERCIST criteria
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startNov 2014
- Primary completionSep 2024
- Study completionSep 2024
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOVERA Christine, Study director, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697084
- Sponsor's protocol ID
- 2014/54
- Acronym
- IFACT
- Status last verified
- Jun 2026
- First submitted
- 22 Feb 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zwarthoed C, Jaraudias C, Evesque L, Baron D, Francois E, Chardin D, Marie L, Mitrea D, Chateau Y, Gal J, Bailleux C. Prognostic Values of Pre- and Post-Therapeutic FDG-PET in Anal Canal Cancer: Analysis of a Prospective Study. Clin Colorectal Cancer. 2025 Jun;24(2):256-263.e8. doi: 10.1016/j.clcc.2025.01.006. Epub 2025 Feb 3.
PubMed 39988512
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Following in Anal Cancer With PET/CT
- ClinicalTrials.gov ID
- NCT02697084
- Acronym / sponsor ID
- IFACT / 2014/54
- Conditions
- Anal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Sep 2024 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 3 Mar 2016 (estimated)
- 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.
Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6% of anorectal cancers. Incidence is less than 1/100 000 of the general population. However, the incidence has increased considerably over the past three decades. The main risk factors are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of the most appropriate treatment strategy will condition the patient's prognosis. Consequently, early assessment of the initial extension of the tumor, its therapeutic response and relapses constitute determining factors in the management of the disease Despite the good results obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage amputation can then prove effective in cases of local or loco-regional relapse. The great majority of relapses occur within 2 years after treatment. Reported prognostic survival factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node involvement.
The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses principally on the clinical examination although the type and frequency of the paraclinical examinations are not backed by any consensus.
Detailed description
Post-treatment 18-FDG PET scan at 2 months can prove useful to predict locoregional or metastatic recurrence in patients treated by radiochemotherapy or radiotherapy in the anal canal cancer setting. There appear to be an FDG intensity variable and a metabolic response criterion enabling establishment of two groups of patients: low recurrence risk versus high recurrence risk at 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canal anal cancer
Key inclusion criteria (1 listed)
- Consecutive inclusion of incident cases of anal canal cancer between November 2014 and May 2018. These patients are volunteers and have signed informed consent.
Key exclusion criteria (2 listed)
- Presence of a nother cancer and specific treatment (chemotherapy, radiotherapy). Follow-up impossible during two years or more.
- Refusal to submit to initial or post-treatment PET/CT.
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 |
|---|---|---|
| anal cancerAnal cancer patients with TEP TDM | Other | – |
Primary outcome
time of disease-free survival
Time frame: 3 years
8 secondary outcomes
best metabolic response measurement variable: SUVmax
Time frame: 3 years
best metabolic response measurement variable: SUVmean
Time frame: 3 years
best metabolic response measurement variable: SUL peak
Time frame: 3 years
best metabolic response measurement variable: Metabolic Total Volume (MTV)
Time frame: 3 years
best metabolic response measurement variable: Total Lesion Glycolysis (TLG)
Time frame: 3 years
best treatment response criterion: SUV or metabolic volume threshold
Time frame: 3 years
best treatment response criterion: ratio (SUV or metabolic volume)
Time frame: 3 years
best treatment response criterion: complete or partial metabolic response according to EORTC or PERCIST criteria
Time frame: 3 years
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 12 Jun 2026.
- Results publication: PubMed 39988512Zwarthoed C, Jaraudias C, Evesque L, Baron D, Francois E, Chardin D, Marie L, Mitrea D, Chateau Y, Gal J, Bailleux C. Prognostic Values of Pre- and Post-Therapeutic FDG-PET in Anal Canal Cancer: Analysis of a Prospective Study. Clin Colorectal Cancer. 2025 Jun;24(2):256-263.e8. doi: 10.1016/j.clcc.2025.01.006. Epub 2025 Feb 3.
- Individual participant dataSharing planned: No
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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.
LOVERA Christine study director
Centre Antoine Lacassagne
1 site 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 Antoine Lacassagne at 1 site 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 1 inclusion and 2 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
time of disease-free survival (time frame: 3 years). 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 NCT02697084, 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 12 Jun 2026.