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

NCT ID: NCT05939401

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2029-12-01

Brief Summary

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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

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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.

Conditions

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Anal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biopsies

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed or recurrent anal cancer

Exclusion Criteria

* No diagnosis of anal cancer, contraindication to biopsies and blood samples
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eva Angenete

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, , Sweden

Site Status RECRUITING

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Eva Angenete PI, Professor

Role: CONTACT

+46760514441

Facility Contacts

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Eva Angenete, MD,PhD

Role: primary

+46313438410

Rebecka Levenskog

Role: backup

Other Identifiers

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ANCABio

Identifier Type: -

Identifier Source: org_study_id

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