Screening for Hepatitis Virus B Protein X (HBx) in Colitis-associated Cancer (CAC)
Launched by IRCCS SAN RAFFAELE · Feb 12, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a specific protein called HBx, which comes from the Hepatitis B Virus (HBV). Researchers have found that this protein appears more often in patients with Ulcerative Colitis (UC) than in healthy people or those with other similar conditions. They believe that HBx may lead to inflammation in the colon, which could increase the risk of developing colitis-associated colorectal cancer (CAC). The study will analyze tissue samples from patients diagnosed with CAC to see if HBx plays a role in this process.
To be eligible for this trial, participants must be adults (18 years or older) who have been diagnosed with CAC, colorectal cancer, diverticulitis, or Crohn's disease, and who have not had a history of Hepatitis B infection. Participants will need to sign consent for their clinical data to be used in research. The trial is still in the planning stages and is not yet recruiting participants. If you or someone you know fits these criteria, this study could provide valuable insights into the connection between HBx and cancer in patients with colitis.
Gender
ALL
Eligibility criteria
- 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.
About Irccs San Raffaele
IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, , Italy
Patients applied
Trial Officials
Silvio Danese, PhD-MD
Study Director
IRCCS San Raffaele
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported