|- candidate number||3531|
|- NTR Number||NTR1367|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-jun-2008|
|- Secondary IDs||MEC 08-2-038 |
|- Public Title||Non-invasive markers for colorectal cancer screening. |
|- Scientific Title||Non-invasive markers for colorectal neoplasia: A multi-marker approach in screening for colorectal cancer|
|- hypothesis||Non-invasive markers have an additional role in screening and surveillance of patients at high risk for CRC. |
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer, Risk factors, Neoplasia, Screening, Family history|
|- Inclusion criteria||- 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.
- Furthermore patients diagnosed with CRC will be included.
|- Exclusion criteria||Individuals will be excluded if:|
1. Younger than 18 years of age
2. Diagnosed with inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
3. Diagnosed with major co-morbidity which may interfere with the outcome of the study (e.g. severe cardiovascular or pulmonary disease, other malignancies)
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2008|
|- planned closingdate||1-sep-2010|
|- Target number of participants||410|
|- Interventions||Collection of blood and fecal samples (once). Non-invasive markers for colorectal neoplasia will be determined in blood, feces and tissue. All combinations of markers will be tested in order to optimize the diagnostic accuracy for colorectal neoplasia, considering the outcome of colonoscopy as the gold standard. In addition the results of the non-invasive markers in patients at high-risk will be compared with the results of an average-risk population, in order to identify risk factors. |
|- Primary outcome||Diagnostic accuracy of molecular and protein markers in screening for colorectal neoplasia in subjects at high-risk for CRC and CRC patients, in comparison with average-risk subjects.
|- Secondary outcome||The role of non-invasive markers in risk stratification of patients at high-risk for CRC. |
|- Timepoints||2 years|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. S. Sanduleanu|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S. Sanduleanu|
|- Sponsor/Initiator ||University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|University Hospital Maastricht (AZM)|
|- Brief summary||Rationale: Colonoscopy is considered to be the gold standard for the detection of colorectal neoplasia. However, this method has important disadvantages, such as invasiveness, complication risk, and possible shortage of clinical capacity. Therefore, the potential additional role of non-invasive screening methods as pre-selection tool for colonoscopy, deserves further investigation. Non-invasive markers for CRC have recently been developed for blood and feces. These markers are currently tested in an average-risk population. In patients at high-risk, as a result of a positive family history, the clinical utility of these markers as pre-selection tool has not been investigated yet. Likewise, no data are available regarding the potential role of these markers in risk stratification of these patients. The clinical utility of such markers to identify risk profiles and hence, to design more individualized surveillance strategies, deserves further investigation.
Two issues will be addressed:
I. To study the diagnostic accuracy of molecular and protein markers in screening for colorectal neoplasia in subjects at high-risk for CRC and CRC patients, in comparison with average-risk subjects.
II. To investigate the role of non-invasive markers in risk stratification of patients at high-risk for CRC. To provide insights in the molecular features of patients at high-risk.
For this purpose, a prospective, cross-sectional study will be performed. The following groups of patients will be included:
i) 200 patients with a family history of CRC and
ii) 150 patients diagnosed with CRC.
Medical data will be collected, all subjects will undergo colonoscopy and non-invasive markers for colorectal neoplasia will be investigated in blood and fecal samples. Additionally, a subset of patients with a non-colorectal gastrointestinal malignancy (e.g. esophageal, gastric or pancreatic cancer) will be included in order to investigate the influence of these lesions on the non-invasive markers profile.
|- Main changes (audit trail)|
|- RECORD||25-jun-2008 - 13-nov-2008|