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NCT Number: NCT05939401

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

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.

Recruiting

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Surgery, Sahlgrenska University Hospital/Ostra, Gothenburg, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed or recurrent anal cancer

Exclusion criteria

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

Treatment and study plan

biopsies

Other

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

Primary outcomes

  1. Tumour micro environment

    Time frame: 2024-2029

    Evaluation of immuncell infiltrates in the tumour micro environment

  2. ctDNA

    Time frame: 2024-2029

    circulating tumour DNA

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Angenete PI, Professor

CONTACT

[email protected]

+46760514441

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Acronym: ANCABio

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Jul 11, 2023
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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