We aim to estimate the sensitivity and specificity of the CELTiC panel in FIT-positive populations.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: sensitivity of the CELTiC panel for detecting advanced neoplasia at a
threshold with an expected sensitivity of 90%;
Secondary outcome
Secondary: specificity and positive predictive value of the CELTiC panel for
detecting advanced neoplasia at a threshold with an expected sensitivity of
90%; specificity and positive predictive value of the CELTiC panel for
detecting advanced neoplasia at a threshold with an observed sensitivity of
90%; C-statistic of the CELTiC panel; association between CELTiC score and FIT
concentration.
Background summary
Colorectal Cancer (CRC) is one of the leading causes of cancer in developed
regions around the world and its incidence is rising. Many nations or regions
have introduced CRC population screening programmes to detect cancerous lesions
before symptoms arise or to detect precursor lesions whose eradication may
prevent CRC.
The Faecal Immunochemical Test (FIT) is used to screen for CRC in many nations
and regions around the world. Its advantages include ease of use, the ability
to be performed at home and to be sent by mail to a laboratory, and its
cost-efficiency. Moreover, these characteristics enable population-wide
screening without the need for all participants to undergo a colonoscopy.
However, a downside of the FIT is its performance. In the Netherlands, where a
FIT cut-off concentration of 47 mcg Hb/g faeces is used, the FIT produces a
negative result in 15% of people who have CRC. For the detection of CRC and
Advanced Adenomas (AA), referred to as Advanced Neoplasia (AN), the FIT falsely
provides a negative result in up to 70% of people with AN. In addition, more
than half of the people with a positive FIT result in the Netherlands do not
have any (pre)cancerous lesions at colonoscopy.
One way to improve the efficiency of CRC screening is to introduce a second
test to FIT-positive screening participants, to further select individuals for
a colonoscopy. Ideally, this test should have a high sensitivity since a false
negative result would lead to denying a colonoscopy to a FIT-positive
individual with a (pre)cancerous lesion. In addition, the specificity of this
test should be high enough to substantially reduce the number of FIT-positive
individuals without AN undergoing colonoscopy.
The CELTiC panel is a blood-based test comprising of four mRNA markers (LGALS4,
CEACAM6, TSPAN8, and COL1A2). In a sample of 128 individuals the panel reached
an AUC of 0.82 in discriminating individuals with AN (n = 92; AA n = 25, CRC n
= 67) from individuals with a positive FIT result but a normal colonoscopy (n =
36). The CELTiC panel could potentially function as a second test for
individuals with a positive FIT result and reduce the number of unnecessary
colonoscopies7. Furthermore, by simultaneously lowering the cut-off
concentration of the FIT and introducing the CELTiC panel, screening programs
may potentially detect more individuals with AN without increasing the number
of colonoscopies performed.
This will be the first study prospectively investigating the CELTiC panel in a
large cohort sourced exclusively from the target population. We therefore
believe this study will add important knowledge on the accuracy of the CELTiC
panel in a realistic clinical setting.
Study objective
We aim to estimate the sensitivity and specificity of the CELTiC panel in
FIT-positive populations.
Study design
We designed an international multicentre cross-sectional and observational
study in two separate screening populations (Italy and the Netherlands)
Study burden and risks
If blood sampling through a peripheral venous catheter fails, we will draw a
blood sample through venepuncture. This procedure may cause pain and
discomfort, albeit tolerably and temporary.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Individuals with a positive FIT test in the national CRC screening program of
the Netherlands and Italy, between 55 and 75 years old (Netherlands), or 50 and
69 years old (Italy).
Exclusion criteria
Individuals with Inflammatory Bowel Disease, under current treatment of
colorectal cancer, or under current endoscopic surveillance.
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 | NL77730.018.21 |