NCT05939401

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Dec 2023Dec 2029

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

July 3, 2023

Last Update Submit

March 13, 2025

Conditions

Anal Cancer

Keywords

Anal cancer, Tumour micro environment, Chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

  • Tumour micro environment

    Evaluation of immuncell infiltrates in the tumour micro environment

    2024-2029

  • ctDNA

    circulating tumour DNA

    2024-2029

Interventions

BiopsiesOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to Sahlgrenska University Hospital with anal cancer

You may qualify if:

  • Newly diagnosed or recurrent anal cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour tissue, adjacent normal tissue, blood samples

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Eva Angenete PI, Professor

CONTACT

+46760514441eva.angenete@gu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)