Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06325891 |
| Other study ID # |
RP025 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
King Chulalongkorn Memorial Hospital |
| Contact |
Thanrada Vimonsuntirungsri, MD |
| Phone |
+66853356240 |
| Email |
aa_choc[@]docchula.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Many studies have shown a significant change of diversity and composition in gut microbiota
across the gastric carcinogenesis process, particularly in patients with gastric cancer.
However, there has been no analysis of gastric microbiota using the mucosal brushing
technique, despite its favoring benefit in microbiota study. Therefore, this study aims to
evaluate microbiota profile in patients with gastric cancer, compared to those without
gastric cancer by using mucosal brush sampling. This will improve current knowledge of the
potential role of the microbiome in patient gastric cancer as a future biomarker marker using
brushing sampling.
Description:
- Gut microbiota play role in mucosal immune response and strength gut integrity. The
dysbiosis or imbalance of microbiota changes microecology and activates the inflammation
in gastrointestinal mucosa. It also has been implicated in gastric carcinogenesis.
- Up to date, many studies have shown a significant change of diversity and composition in
gut microbiota across the gastric carcinogenesis process, particularly in patients with
gastric cancer. Although, Helicobacter pylori infection is potential class I carcinogen
in initial step of gastric carcinogenesis, only between 1% and 3% of patient with H.
pylori infection develop gastric cancer. In addition, many current studies have revealed
significant change in microbiome profile of patient with H. pylori-negative gastric
cancers. Many studies have revealed significant change in microbiome profile of patient
with H. pylori-negative gastric cancers. Therefore, the investigators have hypothesized
that unidentified non-H. pylori bacteria play a role in gastric cancer development.
- However, most of current studies of gastric microbiota in patients with gastric cancer
have been conducted in Eastern Asia, particularly in China and Korea, there is still no
published data from Thailand. Moreover, all previous studies have used gastric tissue
biopsy method. There has been no analysis of gastric microbiota using the mucosal
brushing technique, despite its favoring benefit in microbiota study
- This study is pilot phase, cross-sectional and case-control study that aims to evaluate
microbiota profile in patients with gastric cancer, compared to those without gastric
cancer by using mucosal brush sampling.
- According to previous studies, H. pylori had significant impact on the composition of
gastric microbiota. Presence of H. pylori could affect the result of the study.
Therefore pre-specified subgroup analysis of H.pylori infection and non-H.pylori
infection will be perform.
- Study protocol include
- Age, gender, BMI, smoking history, history of PPI use within 3 months, history of
infection within 2 weeks, history of antibiotic use within 3months, history of probiotic
use within 3months, history of intraabdominal surgery, history of dietary supplement and
herbal use will be recorded in case record form.
- After consent, standard EGD will be performed.
- The gastric mucosa using mucosal brushing with sterile sheathed brush, gastric mucosal
biopsy by standard forceps biopsy and rapid urease test for evaluate H.pylori status
will be done respectively.
- The gastric mucosal specimen will be keep in sterile tube and immediate keep in freezing
at -80C (allow room temperature <2 hr) for 16sRNA sequencing analysis.
