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NCT05939401 Clinical Trial

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

Anal Cancer Clinical Trial

— ANCABio  

Official title:
ANCABio - a Study Regarding Tumour Microenvironment and the Predictive Capability of Biopsies From Anal Cancer in Predicting Response and Outcome

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05939401
Other study ID # ANCABio
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 1, 2029

Study information
Verified date December 2023
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date December 1, 2029
Est. primary completion date December 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Newly diagnosed or recurrent anal cancer Exclusion Criteria: - No diagnosis of anal cancer, contraindication to biopsies and blood samples

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Sweden Dept. of Surgery, Sahlgrenska University Hospital/Ostra Gothenburg

Sponsors (2)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumour micro environment Evaluation of immuncell infiltrates in the tumour micro environment 2024-2029
Primary ctDNA circulating tumour DNA 2024-2029
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