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Screening for Hepatitis Virus B Protein X (HBx) in Colitis-associated Cancer (CAC)

NCT06833021 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2025-02-20

No results posted yet for this study

Summary

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

  • Colitis-associated Colorectal Cancer (CAC)

Interventions

OTHER

Transcriptomic Analysis

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.

OTHER

Transcriptomic Analysis

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. FFPE tissue blocks from CRC, diverticulitis, IC and CD without cancer patients will be utilized as controls.

Sponsors & Collaborators

  • IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

    collaborator UNKNOWN

  • Western University, Canada

    collaborator OTHER

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Silvio Danese, PhD-MD · IRCCS San Raffaele

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06833021 on ClinicalTrials.gov