ANALYSIS OF SPECIFIC BIOMARKERS
Analyses of serum Nucleosomes and histone modifications in samples from the first 4,000 of the 8,415 subjects with positive stool samples (FIT-positive) from our most recently completed research project have shown:
the inclusion of blood samples from people who have FIT concentration> 100 but <400 ng (occult blood) per ml (faeces) could detect more than half of the individuals with bowel neoplasia.
Subjects who, otherwise, would be missed with the cut-off level increased to 400 ng/ml to comply with the request of subsequent screening colonoscopies.
Calculations show that triage including a FIT test result in combination with a blood test result may reduce the request for screening colonoscopies with about 25%.
The current screening for colorectal cancer in Denmark has been and continues to be a great success. In the past 22 months screening has identified 2,041 patients with colorectal cancer, and 10,566 patients with premalignant colonic lesions – high and medium-risk adenomas Lesions that would have developed into colorectal cancer, hence, these had not been identified and removed.
Note, that none of the patients had had symptoms ahead of the screening. Similar successful results have been achieved in, also, other European countries.
The screening success is unfortunately resulting in an upcoming lack of capacity to complete the required number of colonoscopies. This impact has in other comparable countries resulted in the decision to raise the threshold (cut-off) between a declared positive ctr. negative finding in the applied stool test.
Successen har den uheldige virkning, at der for nuværende ikke er kapacitet til at gennemføre det nødvendige antal koloskopier. Denne konsekvens har i flere lande medført en beslutning om at at hæve grænsen (cut-off) mellem et erklæret positivt eller negativt fund i den anvendte afføringstest.
From 2018 Denmark will, probably, also have to raise the cut-off level from eg 100 ng/ml to 400 ng/ml. Our research shows that does this happen, 9% of those who may have colorectal cancer and 30% of those who may have high or medium-risk premalignant lesions will pass the screening unidentified.
Our preliminary results lead to considerations of studying the logistic and feasibility of the triage screening concept.
The trial will focus on subjects, who in the general screening for colorectal cancer have a FIT negative result > 100 but <400 ng/ml and, also, accepts the current offer of colonoscopy.
Based on these criteria subjects from the Capital Region of Denmark will be randomly selected and prompted a blood sample to the project. The logistics to achieve the necessary blood analyses and the subsequent decision of possible colonoscopy will be identified. The outcome of this triage will be compared with the result of the person’s completed colonoscopy.
The regional screening groups are informed about our upcoming project and the possible impact on future screening. Thus, the use of triage in general screening, is ready to be introduced in Denmark if it becomes necessary to raise the cut-off level to 400 ng/ml—expectedly from January 2018. In the meantime our research will focus on whether the final analysis results of other possible biomarkers could improve our triagering concept.