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Recruiting NCT05939401

A Study Regarding Tissue Response During and After Treatment for Anal Cancer

Observational Anal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsies.
Who it may be relevant to
Registry conditions: Anal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ANCABio - a Study Regarding Tumour Microenvironment and the Predictive Capability of Biopsies from Anal Cancer in Predicting Response and Outcome

Overview

The aim of this study is to improve the understanding for the tumour biology in relation to treatment response in patients with anal cancer by examining: * The tumour microenvironment * The localisation of and cellular interactions between the tumour and immune cells * The gene and protein expression by cells present in the tumour and surrounding tissue.

Detailed description

All adult patients with anal cancer presenting within the Sahlgrenska University Hospital catchment area or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. The patients that are newly diagnosed or that have a suspected recurrence will be offered to enter the study with biopsies as well as blood samples during the diagnostic examination that is performed under anaesthesia. Biopsies will then be taken during follow-up exams if applicable. Biopsies will also be taken during surgery if that is scheduled and in cases where surgery is not necessary biopsies will be taken if the patient undergoes examinations under anaesthesia after treatment cessation.

If it is not possible to take biopsies prior treatment blood samples will still be drawn.

Interventions

  • Other Biopsies
    Biopsies and blood samples will be taken at time of diagnosis or recurrence

Primary outcome measures

  • Tumour micro environment [Time frame: 2024-2029]
  • ctDNA [Time frame: 2024-2029]

Eligibility criteria

Inclusion criteria

  • Newly diagnosed or recurrent anal cancer

Exclusion criteria

  • No diagnosis of anal cancer, contraindication to biopsies and blood samples

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 2 centers
  • Dept. of Surgery, Sahlgrenska University Hospital/Ostra — Gothenburg
  • Sahlgrenska University Hospital — Gothenburg

Identifiers

NCT: NCT05939401 · ANCABio

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗