Towards an Understanding of Barriers and Delays in the Diagnosis of Anal Cancer (FRACAS)

August 28, 2026 updated by: Centre Hospitalier Intercommunal Creteil
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.

Study Overview

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

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with squamous cell carcinoma of the anal canal

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years
  2. Histologically proven invasive or microinvasive squamous cell carcinoma of the anus
  3. 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)

  4. Affiliated with a social security system

Exclusion Criteria:

  1. Refusal to participate in the protocol
  2. Other histological types: lymphoma, adenocarcinoma, neuroendocrine tumor, etc.
  3. Time since treatment initiation greater than 6 months
  4. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

February 1, 2026

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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