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

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

NCT ID: NCT05939401

Condition: Anal Cancer

Conditions: Official terms:
Anus Neoplasms

Conditions: Keywords:
Anal cancer, Tumour micro environment, Chemoradiotherapy

Study type: Observational [Patient Registry]

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Biopsies
Description: Biopsies and blood samples will be taken at time of diagnosis or recurrence

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.

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.

Criteria for eligibility:

Study pop:
Patients referred to Sahlgrenska University Hospital with anal cancer

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Newly diagnosed or recurrent anal cancer Exclusion Criteria: - No diagnosis of anal cancer, contraindication to biopsies and blood samples

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Address:
City: Gothenburg
Zip: SE 416 85
Country: Sweden

Start date: December 1, 2023

Completion date: December 1, 2029

Lead sponsor:
Agency: Sahlgrenska University Hospital, Sweden
Agency class: Other

Collaborator:
Agency: Göteborg University
Agency class: Other

Source: Sahlgrenska University Hospital, Sweden

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05939401