Anal CancerANCABioNCT05939401
A Study Regarding Tissue Response During and After Treatment for Anal Cancer
An observational study of Anal Cancer, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- Biopsies
- How many people
- 400 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Dec 2023to 1 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to Sahlgrenska University Hospital with anal cancer
Who may be able to join
- Newly diagnosed or recurrent anal cancer
Who cannot join
- No diagnosis of anal cancer, contraindication to biopsies and blood samples
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
Eva Angenete, MD,PhD, +46313438410, eva.angenete@vgregion.se
Rebecka Levenskog, rebecka.levenskog@gu.se
- Recruiting
Sahlgrenska University Hospital
Gothenburg
About this study
Official title: ANCABio - a Study Regarding Tumour Microenvironment and the Predictive Capability of Biopsies from Anal Cancer in Predicting Response and Outcome
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.
Read the 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.
- Conditions
- Anal Cancer
- Being tested
- Biopsies
- Keywords
- Anal cancer, Tumour micro environment, Chemoradiotherapy
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsiesOther
Biopsies and blood samples will be taken at time of diagnosis or recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour micro environment
Evaluation of immuncell infiltrates in the tumour micro environment
Measured: 2024-2029
ctDNA
circulating tumour DNA
Measured: 2024-2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939401
- Sponsor's protocol ID
- ANCABio
- Acronym
- ANCABio
- Status last verified
- Mar 2025
- First submitted
- 3 Jul 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANCABio - a Study Regarding Tumour Microenvironment and the Predictive Capability of Biopsies from Anal Cancer in Predicting Response and Outcome
- ClinicalTrials.gov ID
- NCT05939401
- Acronym / sponsor ID
- ANCABio / ANCABio
- Conditions
- Anal Cancer
- Keywords
- Anal cancer, Tumour micro environment, Chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to Sahlgrenska University Hospital with anal cancer
Key inclusion criteria (1 listed)
- Newly diagnosed or recurrent anal cancer
Key exclusion criteria (1 listed)
- No diagnosis of anal cancer, contraindication to biopsies and blood samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsiesBiopsies and blood samples will be taken at time of diagnosis or recurrence | Other | – |
Primary outcome
Tumour micro environment
Time frame: 2024-2029
Evaluation of immuncell infiltrates in the tumour micro environment
ctDNA
Time frame: 2024-2029
circulating tumour DNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by Sahlgrenska University Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Angenete PI, Professor (+46760514441, eva.angenete@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour micro environment (time frame: 2024-2029). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.