Crohn'sNot yet recruiting
Screening for Hepatitis Virus B Protein X (HBx) in Colitis-associated Cancer (CAC)
Observational · No treatment assigned · 1 site · IRCCS San Raffaele
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Colitis-associated Colorectal Cancer (CAC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 66 participants are expected to take part.
- Start date: 2025-04-01 (planned).
- Main results expected around 2026-04-01 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- To define HBx as a predictive biomarker of CAC in UC patients (Being a retrospective study, we plan to collect FFPE stored from October 2021 to December 2024. Duration of total study…)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Colitis-associated Colorectal Cancer (CAC) |
| Lead sponsor | IRCCS San Raffaele |
| Collaborators | IRCCS Casa Sollievo della Sofferenza; Western University, Canada |
| Enrollment | 66 (estimated) |
| Start date | 2025-04-01 |
| Primary completion (est.) | 2026-04-01 |
| First posted | 2025-02-18 |
| Last updated | 2025-02-20 |
| Official title | Multicenter Retrospective Study on Hepatitis B Virus Protein X (HBx) Screening in Patients With Colitis-associated Cancer (CAC) |
| ClinicalTrials.gov ID | NCT06833021 |
Interventions
- Transcriptomic Analysis (Other)
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. - Transcriptomic Analysis (Other)
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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele | Milan, Italy | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.