Checking colon tissue from people with colitis-linked colon cancer for a hepatitis B protein
Looks for a hepatitis B protein in colon tissue from adults with colitis cancer.
Key facts
- Who runs it
- IRCCS San Raffaele
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- Screening for Hepatitis Virus B Protein X (HBx) in Colitis-associated Cancer (CAC)
- Status
- Not yet recruiting
- People taking part
- 66 people, planned
- Started
- 1 Apr 2025
- Planned end
- 1 Apr 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Transcriptomic Analysis
- Record updated
- 20 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a biopsy or surgery for colitis-associated cancer, colorectal cancer, diverticulitis, indeterminate colitis or Crohn's disease, with no known hepatitis B infection.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Colitis-associated cancer, colorectal cancer, diverticulitis, indeterminate colitis or Crohn's disease, diagnosed through a biopsy or surgery done from 2021 to 2024.
- Earlier treatment
- Must have had an endoscopic biopsy or surgical removal (resection) as part of standard care.
- Biomarker or test result
- No documented history of hepatitis B virus (HBV) infection.
Main reasons for not taking part
- Under 18 years of age
- Documented history of HBV infection
- Has not signed the informed consent for use of clinical data in research
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- adult patients (age ≥18 years), both male and female, diagnosed with CAC, CRC, diverticulitis, IC or CD who had previously undergone endoscopic biopsy or surgical resection, according to standard clinical practice (from 2021 to 2024)
- patients with no documented history of HBV infection
- patients who had already signed the informed consent authorizing the use of their clinical data for future scientific research
Who cannot take part
- patients under 18 years of age
- adult patients (age ≥18 years), both male and female diagnosed with CAC, CRC, diverticulitis, IC or CD with a documented history of HBV infection
- patients who have not signed the informed consent authorizing the use of their clinical data for future scientific research
Where in Italy
- IRCCS San RaffaeleMilan, ItalyContact: Federica Ungaro, PhD.Not yet recruiting
About the trial
What the trial wants to find out
It was recently discovered that a protein from the Hepatitis B Virus (HBV), called HBx, is highly present in patients who were recently diagnosed with Ulcerative Colitis (UC). This was more common in UC patients than in healthy individuals or those with Crohn's Disease. About 45% of the UC patients studied had this protein, possibly due to a virus jumping from animals to humans.
Read full original descriptionShow less
In experiments with mice, it was found that HBx alone can cause colitis (inflammation of the colon) by disrupting the normal function of the gut lining. This disruption leads to inflammation and immune system problems in the colon, even without other bacteria being involved. Mice treated with HBx showed fewer immune cells, which are crucial for resolving inflammation and fighting infections. This aligns with current theories about how UC develops.
Additionally, HBx affects the genes in the gut lining, promoting cell growth and changes that could lead to cancer. In human colon tissue samples, HBx activated processes linked to the Wnt pathway, which is known to be involved in colorectal cancer. This is similar to how HBx behaves in liver cells infected with HBV, where it prevents DNA repair and leads to cancer.
Based on these findings, it is believed that HBx disrupts the balance in the gut, causing chronic inflammation that could progress to cancer. To explore this further, a study is being conducted to detect HBx in tissue samples from patients with colitis-associated cancer (CAC). Advanced techniques will be used to analyze these samples and compare them with samples from patients with other conditions like diverticulitis, indeterminate colitis, and Crohn's disease without cancer
The 2 groups in the trial
- Control Group
33 patients used as control including patients with CRC not associated with colitis, diverticulitis, IC and CD without cancer.
Treatment: Transcriptomic Analysis
- Case Group
33 patients diagnosed with CAC
Treatment: Transcriptomic Analysis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multicenter Retrospective Study on Hepatitis B Virus Protein X (HBx) Screening in Patients With Colitis-associated Cancer (CAC)
- Plain-language title
- Checking colon tissue from people with colitis-linked colon cancer for a hepatitis B proteinGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 20 February 2025