- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07455942
Towards an Understanding of Barriers and Delays in the Diagnosis of Anal Cancer (FRACAS)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Camille JUNG, PhD
- Phone Number: +33 (0)1 57 02 50 00
- Email: camille.jung@chicreteil.fr
Study Contact Backup
- Name: Isabelle ETIENNEY, MD
- Phone Number: +33 (0)1 44 64 20 16 51
- Email: ietienney@hopital-dcss.org
Study Locations
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Angers, France, 49933
- Recruiting
- CHU Angers
-
Contact:
- Aurélien VENARA, PhD
- Email: AuVenara@chu-angers.fr
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Avignon, France, 84000
- Not yet recruiting
- CH Avignon
-
Contact:
- Julie SIEGRAND, MD
- Email: Sigrand.julie@ch-avignon.fr
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Bayonne, France, 64100
- Recruiting
- Clinique Belharra
-
Contact:
- Milène ISAMBERT, MD
- Email: mileneisambert@hotmail.com
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Beuvry, France, 62660
- Recruiting
- CH Béthune
-
Contact:
- Perrine MORTREAUX, MD
- Email: pmortreux@ch-bethune.fr
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Cholet, France, 49300
- Recruiting
- Polyclinique du Parc Vivalto
-
Contact:
- Carine KORKMAZ
- Email: ckorkmaz@vivalto-sante.com
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Château-Gontier, France, 53200
- Recruiting
- CH du Haut Anjou
-
Contact:
- Denis MARTIN, MD
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Créteil, France, 94000
- Recruiting
- Centre Hospitalier Intercommunal de Créteil
-
Contact:
- Isabelle RPOSA, PhD
- Email: isabelle.rosa@chicreteil.fr
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Grasse, France, 06130
- Recruiting
- Clinique du Palais
-
Contact:
- CHANUT Laurie, MD
- Email: chanutlaurie@gmail.com
-
La Roche-sur-Yon, France, 85925
- Recruiting
- CH Vendée
-
Contact:
- Marc-Henri JEAN, MD
- Email: marc-henri.jean@ght85.fr
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Le Bouscat, France, 33110
- Recruiting
- Cabinet de proctologie
-
Contact:
- JUGUET Frédéric, MD
- Email: proctologues.bordeaux@gmail.com
-
Lens, France, 62300
- Recruiting
- CH Lens
-
Contact:
- Flavien DAUTRECQUE, MD
- Email: fdautrecque@ch-lens.fr
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Lyon, France, 69007
- Recruiting
- Hôpital St Joseph St Luc
-
Contact:
- Aurélien GARROS, MD
- Email: agarros@saintjosephsaintluc.fr
-
Marseille, France, 13006
- Recruiting
- CHU Hôpital Nord - Marseille
-
Contact:
- Ana BEYRNE, MD
- Email: ana.beyrne@ap-hm.fr
-
Montpellier, France, 34090
- Recruiting
- CHU Montpellier
-
Contact:
- Emile MALEZIEUX, MD
- Email: e-malezieux@chu-montpellier.fr
-
Montpellier, France, 34298
- Recruiting
- Institut Regional Du Cancer de Montpellier (Icm)
-
Contact:
- Claire LEMANSKI, MD
- Email: Claire.Lemanski@icm.unicancer.fr
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Orléans, France, 45000
- Recruiting
- Chu Orleans
-
Contact:
- Jean-Paul LAGASSE, MD
- Email: jean-paul.lagasse@chu-orleans.fr
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Orsay, France, 91400
- Recruiting
- Hôpital Paris Saclay, GHNE
-
Contact:
- Edoardo POLI, MD
- Email: e.poli@ghne.fr
-
Paris, France, 75014
- Recruiting
- Hopital Saint Joseph
-
Contact:
- Luca SPINDLER, MD
- Email: lspindler@ghpsj.fr
-
Paris, France, 75020
- Recruiting
- APHP Hôpital Tenon
-
Contact:
- Florence HUGUET, PhD
- Email: florence.huguet@aphp.fr
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Paris, France, 75020
- Recruiting
- Groupe Hospitalier Diaconesses Croix Saint-Simon
-
Contact:
- Sarah TAIEB, MD
- Email: staieb@hopital-dcss.org
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Paris, France, 75014
- Recruiting
- APHP_Hôpital Cochin-Port Royal
-
Contact:
- Johan CHANAL, MD
- Email: johan.chanal@aphp.fr
-
Paris, France, 75014
- Recruiting
- Institut Mutualiste de Montsouris
-
Contact:
- Marie-Lise THIERRY, MD
- Email: thierrymarielise@gmail.com
-
Paris, France, 75018
- Recruiting
- APHP_Hôpital Bichat Claude-Bernard
-
Contact:
- Laurent ABRAMOWITZ, PhD
- Email: laurent.abramowitz@aphp.fr
-
Pau, France, 64000
- Recruiting
- Polyclinique Pau Pyrénées
-
Contact:
- Frédéric NDOBO EPOY, MD
- Email: f.ndoboepoy@orange.fr
-
Poissy, France, 78300
- Recruiting
- CHI Poissy-St Germain
-
Contact:
- BASSO Valéria, MD
- Email: valeria.basso@ght-yvelinesnord.fr
-
Quint-Fonsegrives, France, 31130
- Recruiting
- Maison des consultations
-
Contact:
- Pauline MERLE, MD
- Email: p.merle@gastro-procto31.fr
-
Rennes, France, 35033
- Recruiting
- CHRU Ponchaillou de Rennes
-
Contact:
- Amandine LANDEMAINE, MD
- Email: amandine.landemaine@chu-rennes.fr
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Saint-Grégoire, France, 35760
- Recruiting
- Clinique Saint-Grégoire
-
Contact:
- Agnès SENEJOUX, MD
- Email: agnes.senejoux@gmail.com
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Saint-Mandé, France, 94160
- Recruiting
- HIA Begin
-
Contact:
- Anne-Cécile EZANNO, MD
- Email: anne-cecile.ezanno@intradef.gouv.fr
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Talence, France, 33400
- Recruiting
- Hôpital Bagatelle
-
Contact:
- Dominique BOUCHARD, MD
- Email: proctobouc@gmail.com
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Villeneuve-Saint-Georges, France, 94190
- Recruiting
- Centre Hospitalier Intercommunal de Villeneuve-Saint-Georges
-
Contact:
- Céline SOMSOUK, MD
- Email: celine.somsouk@chiv.fr
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Épagny, France, 74370
- Recruiting
- CH Annecy Genevois
-
Contact:
- Laurence RENAUD, MD
- Email: lrenaud@ch-annecygenevois.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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:
i. 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients diagnosed with squamous cell carcinoma of the anal canal
Adult patients diagnosed with histologically confirmed anal squamous cell carcinoma.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary tumor, regional nodes, metastasis (TNM) ) stage comparison
Time Frame: At the inclusion
|
Comparison of diagnostic stages and patient pathways according to whether or not they underwent scr
|
At the inclusion
|
|
Assessment of Deprivation and Health Inequalities for Health Examination Centers, French
Time Frame: At the inclusion
|
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.
|
At the inclusion
|
|
Link between HPV and anal cancer
Time Frame: At the inclusion
|
Proportion of patients aware of the link between HPV and anal cancer
|
At the inclusion
|
|
Performing a rectal examination at the first consultation
Time Frame: At the inclusion
|
Assess the proportion of patients who underwent a clinical examination with rectal examination at the first consultation
|
At the inclusion
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FRACAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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