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

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05939401
• Collaborator: Göteborg University (Other)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anal Cancer	Other: Biopsies

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ANCABio - a Study Regarding Tumour Microenvironment and the Predictive Capability of Biopsies From Anal Cancer in Predicting Response and Outcome
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2027
• Anticipated Study Completion Date: Sep 1, 2029

Outcome Measures

Primary Outcome Measures

1. Tumour micro environment [2024-2029]

   Evaluation of immuncell infiltrates in the tumour micro environment

2. ctDNA [2024-2029]

   circulating tumour DNA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Newly diagnosed or recurrent anal cancer

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Surgery, Sahlgrenska University Hospital/Ostra	Gothenburg		Sweden	SE 416 85

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden
• Göteborg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eva Angenete, Professor, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT05939401
• Other Study ID Numbers: ANCABio
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 11, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eva Angenete, Professor, Sahlgrenska University Hospital, Sweden: Anal cancer, Tumour micro environment, Chemoradiotherapy
• Additional relevant MeSH terms: Anus Neoplasms

Study Results

No Results Posted as of Jul 11, 2023