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.
Plain-language title generated from the registry record
Registry title: Screening for Hepatitis Virus B Protein X (HBx) in Colitis-associated Cancer (CAC)
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- IRCCS San RaffaeleMilan, ItalyNo longer taking part
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?
Trial details
- Who runs it
- IRCCS San Raffaele
- Trial code
- NCT06833021
- Record updated
- 20 February 2025
- Original description
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
Multicenter Retrospective Study on Hepatitis B Virus Protein X (HBx) Screening in Patients With Colitis-associated Cancer (CAC)
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.
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
Inclusion: 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.
Exclusion: 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.