Objective: Two issues will be addressed:I. To study the diagnostic accuracy of molecular and protein markers in screening for colorectal neoplasia in subjects with either a low-risk or a high-risk for CRC.II. To define a multi-marker approach for…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Test characteristics (sensitivity, specificity, positive predictive value,
negative predictive value and diagnostic accuracy) of different molecular and
protein markers in the detection of colorectal neoplasia in patients with a
low-risk or high-risk for CRC.
Secondary outcome
The identification of risk factors for colorectal neoplasia in subjects at
low-risk and at high-risk for CRC. Subsequently, a multi-marker approach for
risk stratification in these groups of individuals at different risks for CRC
will be designed.
Background summary
Rationale:
Colorectal cancer (CRC) is a major health issue in the Netherlands. Screening
is mandatory to decrease the incidence of CRC and the disease related
mortality. However, the lack of consensus on a single best screening method
reflects the limitations of all currently available strategies. Two groups at
risk for CRC are identified: individuals older than 50 years (low-risk
subjects) and patients with a family history of CRC (high-risk subjects).
Screening in these two groups seems justified. At this moment, the best
screening method for the low-risk group is being investigated in different
medical centres in the Netherlands. For patients at high-risk, surveillance by
colonoscopy is indicated following the national guidelines. Colonoscopy is
considered to be the golden standard for detection of colorectal neoplasia.
However, this method has important disadvantages such as invasiveness,
complication risk, and possible shortage of clinical capacity. Therefore other,
non-invasive, screening methods deserve further investigation.
Non-invasive markers for CRC have been recently developed for blood and faeces.
These markers are currently tested in individuals at low-risk in a workplace
based screening population. In patients at high-risk, as a result of positive
family history, the clinical utility of these markers has not been investigated
yet.
Study objective
Objective:
Two issues will be addressed:
I. To study the diagnostic accuracy of molecular and protein markers in
screening for colorectal neoplasia in subjects with either a low-risk or a
high-risk for CRC.
II. To define a multi-marker approach for risk stratification in these
populations at different risks for CRC.
Study design
Study design:
For this purpose, a prospective, cross-sectional study will be performed. The
following groups of patients will be included: i) 400 individuals participating
in the workplace based CRC screening study, ii) 200 patients with a family
history of CRC and iii) 150 patients with proven CRC. Medical data will be
collected, all subjects will undergo colonoscopy and non-invasive markers for
colorectal neoplasia will be investigated in blood and faeces samples.
Additionally, a subset of patients with a non-colorectal gastrointestinal
malignancy (e.g. oesophageal, gastric or pancreatic cancer) will be included in
order to investigate the influence of these lesions on the test results of the
non-invasive markers.
Study burden and risks
Burden and risks:
venapuncture: local pain and hematoma are possible adverse events
collection of faeces sample: no risks, may be uncomfortable for participant
P. Debyelaan 25
6229 HX Maastricht
NL
P. Debyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
Subjects who will undergo a colonoscopy.
1) average-risk population
Employees (50-65 years of age) from companies participating in the ongoing workplace-based CRC screening project by colonoscopy have already been included.
2) high-risk population
Patients with a positive family history of CRC visiting the *outpatient clinic for hereditary colorectal cancer* or visiting the endoscopy unit of the MUMC+ for surveillance colonoscopy will be asked to participate into the study. This population will include patients with hereditary forms of CRC (Lynch syndrome or FAP) as well as patients fulfilling the criteria for familial CRC syndrome: i) ³ 1 first degree relative (FDR) with CRC diagnosed < 50 year or ii) ³ 2 FDR with CRC diagnosed between 50-70 year or iii) 1 FDR and 1 second degree relative with CRC diagnosed < 70 year.
3) CRC patients
Patients diagnosed with CRC, visiting the *emergency outpatient clinic* of the Division of Gastroenterology-Hepatology after the initial diagnosis of CRC and before subsequent therapeutic interventions are started, will be included.
Additionally, a subset of patients diagnosed with either oesophageal, gastric or pancreatic cancer will be included at our *emergency outpatient clinic* of the Division of Gastroenterology-Hepatology after initial diagnosis and before subsequent therapeutic interventions are started. We will include 20 patients for each group of non-colorectal gastrointestinal malignancy.
Exclusion criteria
Individuals will be excluded if:
-younger than 18 years old
-diagnosed with inflammatory bowel disease (Crohn*s disease or ulcerative colitis)
-diagnosed with major co-morbidity which may interfere with the outcome of the study (e.g. severe cardiovascular or pulmonary disease, other malignancies)
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 | NL22905.068.08 |