Clinical trial · Observational
Screening for Hepatitis Virus B Protein X (HBx) in Colitis-associated Cancer (CAC)
Multicenter Retrospective Study on Hepatitis B Virus Protein X (HBx) Screening in Patients With Colitis-associated Cancer (CAC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis-associated Colorectal Cancer (CAC) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcriptomic Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control Group
- description
- 33 patients used as control including patients with CRC not associated with colitis, diverticulitis, IC and CD without cancer.
- interventionNames
- Other: Transcriptomic Analysis
- label
- Case Group
- description
- 33 patients diagnosed with CAC
- interventionNames
- Other: Transcriptomic Analysis
Primary outcomes (1)
- measure
- To define HBx as a predictive biomarker of CAC in UC patients
- timeFrame
- Being a retrospective study, we plan to collect FFPE stored from October 2021 to December 2024. Duration of total study period: 12 months.
- description
- FFPE tissue blocks from patients diagnosed with CAC, including low- and high-grade dysplasia and adenocarcinoma, obtained from pathological archives will be used. RNA will be extracted and analyzed using RT-PCR to detect and quantify HBx transcripts, with Sanger sequencing employed for further validation of the results. Additionally, FFPE tissue blocks from CRC, diverticulitis, IC and CD without cancer patients will be utilized as controls. FFPE tissue blocks already present in the Pathology Unit will be used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available