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NCT06364579Recruiting

Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).

Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires.

Status (registry)
Recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
28 Mar 2024
Start date
Mar 2024
Primary completion date
Jan 2027
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06364579

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From Mar 2024 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • metastatic disease at diagnosis not amenable to radiochemotherapy treatment

Age

  • age under 18 years

Other

  • Eastern Cooperative Oncology Group (ECOG) higher than 3

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) 0-3
  • minimum 18 years old
  • squamous cell carcinoma of the anal canal
  • low burden of metastatic disease at diagnosis
  • indication for radiochemotherapy treatment
  • informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.