The primary objective of this study is to detect and analyse the microbiome and miRNA in patients with a positive FIT or with a suspicion of adenomas and colorectal cancer at the Erasmus MC.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the analysis of the microbiome and miRNA in
relation to colorectal cancer and adenomas.
Secondary outcome
To assess the possibility of using the microbiome in a FIT as screening tool
for CRC
To assess the possibility of using miRNA panels in a FIT as screening tool for
CRC
To assess the difference in diversity and composition of the microbiome in FIT,
stool sample and mucosal biopsy
To assess the difference in diversity and composition of miRNA in FIT, stool
sample and mucosal biopsy
Background summary
Colorectal cancer (CRC) is one of the major causes of death in the Netherlands,
accounting for almost 5000 deaths in 2014. As most CRCs may develop slowly over
years from precursor lesions, screening and early diagnosis are key to disease
prevention. Nowadays faecal immunochemical testing (FIT), a marker to detect
human haemoglobin, is used as a screening tool for CRC. However, not all
lesions bleed, and conversely, occult blood can on occasion be detected in
fecal samples of otherwise healthy individuals. While the sensitivity of FIT
tests for CRC is around 79%, its specificity for advanced adenomas is only 50%.
Thus, additional tools to identify individuals at risk for CRC, and to reduce
the burden of unnecessary procedures, are called for. Recently, an association
was made between the microbiome and carcinogenesis. This new development could
lead to new markers for the screening of colorectal cancer. In addition,
microRNA (MiRNA) seems to be a modulator in the tumour process as a result of
their role in cell proliferation, differentiation and apoptosis, and have been
suggested to be a stable, valuable biomarker for tumorigenesis.Until now, the
majority of the studies assessed the microbiome and mircroRNA through faecal
samples. However, mucosal tissue and luminal content show considerable
differences in microbial composition. Furthermore, very little is known on
microbiome and miRNA composition in FIT fluid.
The aim of the current study is to investigate whether or not the microbiome
and miRNA can be detected in FIT samples, and function as additional biomarkers
for CRC and adenomas. Secondly, we would like to evaluate whether or not the
microbiome and miRNA differs in composition and diversity when analysed from
FIT, faecal sample and mucosal samples.
Study objective
The primary objective of this study is to detect and analyse the microbiome and
miRNA in patients with a positive FIT or with a suspicion of adenomas and
colorectal cancer at the Erasmus MC.
Study design
Prospective cohort study
Study burden and risks
The additional burden for the patient is to provide two FITs, one stool sample
and fill out one questionnaire. A FIT is a clean and easy method to probe
faecal samples. No extra risks are associated for the participants associated
with the study.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Participants are between 50-75 years old.
- Positive FIT in national CRC screening program
- Suspicion of CRC
- Willing to collect two FIT samples, one stool sample from one stool and fill
out one questionnaire
Exclusion criteria
- Unwilling or not able to give informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60941.078.17 |