Squamous Cell Carcinoma of the Anal CanalFRACASNCT07455942
Towards an Understanding of Barriers and Delays in the Diagnosis of Anal Cancer
An observational study of Squamous Cell Carcinoma of the Anal Canal and HPV-induced Cancer, run by Centre Hospitalier Intercommunal Creteil at 32 sites in France.
Trial summary
This study examines care pathways in 300 patients with anal squamous cell carcinoma to identify barriers and delays in diagnosis, assess the impact of screening and access to care, and improve awareness, screening practices, and early diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Anal Canal, HPV-induced Cancer
- What is being tested?
- self-administered questionnaire
- How many people
- 300 participants
- Where
- 32 sitesFrance
- Study dates
- 23 Jun 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients diagnosed with squamous cell carcinoma of the anal canal
Who may be able to join
- Male or female ≥ 18 years
- Histologically proven invasive or microinvasive squamous cell carcinoma of the anus
- Having read and understood the information letter provided, either:
- After disclosure of the diagnosis, or ii. At the latest 6 months after initiation of treatment (surgical excision, radiotherapy, or chemoradiotherapy)
- Affiliated with a social security system
Who cannot join
- Refusal to participate in the protocol
- Other histological types: lymphoma, adenocarcinoma, neuroendocrine tumor, etc.
- Time since treatment initiation greater than 6 months
- Protected persons (pregnant women, breastfeeding women, individuals under guardianship or curators, minors, persons deprived of liberty, or persons unable to express informed consent).
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
France32 sites, 32 recruiting
- Recruiting
CHU Angers
Angers, 49933
Aurélien VENARA, PhD, AuVenara@chu-angers.fr
- Not yet recruiting
CH Avignon
Avignon, 84000
Julie SIEGRAND, MD, Sigrand.julie@ch-avignon.fr
- Recruiting
Clinique Belharra
Bayonne, 64100
Milène ISAMBERT, MD, mileneisambert@hotmail.com
- Recruiting
CH Béthune
Beuvry, 62660
Perrine MORTREAUX, MD, pmortreux@ch-bethune.fr
- Recruiting
CH du Haut Anjou
Château-Gontier, 53200
Denis MARTIN, MD
- Recruiting
Polyclinique du Parc Vivalto
Cholet, 49300
Carine KORKMAZ, ckorkmaz@vivalto-sante.com
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Isabelle RPOSA, PhD, isabelle.rosa@chicreteil.fr
- Recruiting
CH Annecy Genevois
Épagny, 74370
Laurence RENAUD, MD, lrenaud@ch-annecygenevois.fr
- Recruiting
Clinique du Palais
Grasse, 06130
CHANUT Laurie, MD, chanutlaurie@gmail.com
- Recruiting
CH Vendée
La Roche-sur-Yon, 85925
Marc-Henri JEAN, MD, marc-henri.jean@ght85.fr
- Recruiting
Cabinet de proctologie
Le Bouscat, 33110
JUGUET Frédéric, MD, proctologues.bordeaux@gmail.com
- Recruiting
CH Lens
Lens, 62300
Flavien DAUTRECQUE, MD, fdautrecque@ch-lens.fr
- Recruiting
Hôpital St Joseph St Luc
Lyon, 69007
Aurélien GARROS, MD, agarros@saintjosephsaintluc.fr
- Recruiting
CHU Hôpital Nord - Marseille
Marseille, 13006
Ana BEYRNE, MD, ana.beyrne@ap-hm.fr
- Recruiting
CHU Montpellier
Montpellier, 34090
Emile MALEZIEUX, MD, e-malezieux@chu-montpellier.fr
- Recruiting
Institut régional du Cancer de Montpellier (ICM)
Montpellier, 34298
Claire LEMANSKI, MD, Claire.Lemanski@icm.unicancer.fr
- Recruiting
CHU Orléans
Orléans, 45000
Jean-Paul LAGASSE, MD, jean-paul.lagasse@chu-orleans.fr
- Recruiting
Hôpital Paris Saclay, GHNE
Orsay, 91400
Edoardo POLI, MD, e.poli@ghne.fr
- Recruiting
APHP_Hôpital Cochin-Port Royal
Paris, 75014
Johan CHANAL, MD, johan.chanal@aphp.fr
- Recruiting
Hôpital Saint Joseph
Paris, 75014
Luca SPINDLER, MD, lspindler@ghpsj.fr
- Recruiting
Institut Mutualiste de Montsouris
Paris, 75014
Marie-Lise THIERRY, MD, thierrymarielise@gmail.com
- Recruiting
APHP_Hôpital Bichat Claude-Bernard
Paris, 75018
Laurent ABRAMOWITZ, PhD, laurent.abramowitz@aphp.fr
- Recruiting
APHP Hôpital Tenon
Paris, 75020
Florence HUGUET, PhD, florence.huguet@aphp.fr
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75020
Sarah TAIEB, MD, staieb@hopital-dcss.org
- Recruiting
Polyclinique Pau Pyrénées
Pau, 64000
Frédéric NDOBO EPOY, MD, f.ndoboepoy@orange.fr
- Recruiting
CHI Poissy-St Germain
Poissy, 78300
BASSO Valéria, MD, valeria.basso@ght-yvelinesnord.fr
- Recruiting
Maison des consultations
Quint-Fonsegrives, 31130
Pauline MERLE, MD, p.merle@gastro-procto31.fr
- Recruiting
CHRU Ponchaillou de Rennes
Rennes, 35033
Amandine LANDEMAINE, MD, amandine.landemaine@chu-rennes.fr
- Recruiting
Clinique Saint-Grégoire
Saint-Grégoire, 35760
Agnès SENEJOUX, MD, agnes.senejoux@gmail.com
- Recruiting
Hia Begin
Saint-Mandé, 94160
Anne-Cécile EZANNO, MD, anne-cecile.ezanno@intradef.gouv.fr
- Recruiting
Hôpital Bagatelle
Talence, 33400
Dominique BOUCHARD, MD, proctobouc@gmail.com
- Recruiting
Centre Hospitalier Intercommunal de Villeneuve-Saint-Georges
Villeneuve-Saint-Georges, 94190
Céline SOMSOUK, MD, celine.somsouk@chiv.fr
About this study
This study examines care pathways in 300 patients with anal squamous cell carcinoma to identify barriers and delays in diagnosis, assess the impact of screening and access to care, and improve awareness, screening practices, and early diagnosis.
Read the detailed description
This situational analysis will make it possible to identify barriers and delays in diagnosis, to assess waiting times for access to consultations, and to evaluate the existence of potential fast-track diagnostic pathways.
It will analyze the proportion of cancers diagnosed through screening as well as the proportion of eligible patients who did not benefit from screening.
Assessing patient reluctance, the impact of socio-economic conditions, and patients' knowledge of the link between HPV and anal cancer will help better target public information efforts.
Ultimately, the aim of the study is to improve care pathways in order to enhance public and healthcare professional awareness and promote earlier diagnosis.
- Being tested
- self-administered questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered questionnaireOther
Completion of a self-administered questionnaire by the patient to collect information about their care journey, any difficulties or hesitations, as well as their knowledge of the link between papillomavirus and cancer.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with squamous cell carcinoma of the anal canal | Adult patients diagnosed with histologically confirmed anal squamous cell carcinoma. Receives: Other: self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
First symptom(s) and the histological diagnosis
Time between the first symptom(s) and the histological diagnosis of anal squamous cell carcinoma.
Measured: At the inclusion
Secondary outcomes (4)
Primary tumor, regional nodes, metastasis (TNM) ) stage comparison
Comparison of diagnostic stages and patient pathways according to whether or not they underwent scr
Measured: At the inclusion
Assessment of Deprivation and Health Inequalities for Health Examination Centers, French
French public-health index used to assess an individual's level of social and material deprivation based on living conditions, financial situation, social support, and access to healthcare. It helps identify social health inequalities and adapt medical care accordingly. [0 to 100], The higher the score → the greater the level of deprivation.
Measured: At the inclusion
Link between HPV and anal cancer
Proportion of patients aware of the link between HPV and anal cancer
Measured: At the inclusion
Performing a rectal examination at the first consultation
Assess the proportion of patients who underwent a clinical examination with rectal examination at the first consultation
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start23 Jun 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Anal CanalStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455942
- Sponsor's protocol ID
- FRACAS
- Acronym
- FRACAS
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards an Understanding of Barriers and Delays in the Diagnosis of Anal Cancer
- ClinicalTrials.gov ID
- NCT07455942
- Acronym / sponsor ID
- FRACAS / FRACAS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Mar 2026 (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.
This study examines care pathways in 300 patients with anal squamous cell carcinoma to identify barriers and delays in diagnosis, assess the impact of screening and access to care, and improve awareness, screening practices, and early diagnosis.
Detailed description
This situational analysis will make it possible to identify barriers and delays in diagnosis, to assess waiting times for access to consultations, and to evaluate the existence of potential fast-track diagnostic pathways.
It will analyze the proportion of cancers diagnosed through screening as well as the proportion of eligible patients who did not benefit from screening.
Assessing patient reluctance, the impact of socio-economic conditions, and patients' knowledge of the link between HPV and anal cancer will help better target public information efforts.
Ultimately, the aim of the study is to improve care pathways in order to enhance public and healthcare professional awareness and promote earlier diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with squamous cell carcinoma of the anal canal | – | Other: self-administered questionnaireAdult patients diagnosed with histologically confirmed anal squamous cell carcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with squamous cell carcinoma of the anal canal
Key inclusion criteria (5 listed)
- Male or female ≥ 18 years
- Histologically proven invasive or microinvasive squamous cell carcinoma of the anus
- Having read and understood the information letter provided, either:
- Affiliated with a social security system
Key exclusion criteria (4 listed)
- Refusal to participate in the protocol
- Other histological types: lymphoma, adenocarcinoma, neuroendocrine tumor, etc.
- Time since treatment initiation greater than 6 months
- Protected persons (pregnant women, breastfeeding women, individuals under guardianship or curators, minors, persons deprived of liberty, or persons unable to express informed consent).
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 |
|---|---|---|
| self-administered questionnaireCompletion of a self-administered questionnaire by the patient to collect information about their care journey, any difficulties or hesitations, as well as their knowledge of the link between papillomavirus and cancer. | Other | Patients diagnosed with squamous cell carcinoma of the anal canal |
Primary outcome
First symptom(s) and the histological diagnosis
Time frame: At the inclusion
Time between the first symptom(s) and the histological diagnosis of anal squamous cell carcinoma.
4 secondary outcomes
Primary tumor, regional nodes, metastasis (TNM) ) stage comparison
Time frame: At the inclusion
Assessment of Deprivation and Health Inequalities for Health Examination Centers, French
Time frame: At the inclusion
Link between HPV and anal cancer
Time frame: At the inclusion
Performing a rectal examination at the first consultation
Time frame: At the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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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.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Anal Canal and HPV-induced Cancer, run by Centre Hospitalier Intercommunal Creteil at 32 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille JUNG, PhD ((0)1 57 02 50 00 ext. +33, camille.jung@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First symptom(s) and the histological diagnosis (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.