Colorectal Cancer
Conditions
Brief summary
The present study aims to compare effectiveness and cost-effectiveness of the miRFec test with respect to fecal immunochemical test (FIT) for the detection of advanced colorectal neoplasm among individuals participating in colorectal cancer (CRC) screening, surveillance and diagnosis.
Detailed description
The miRFec test -a Gradient Boosting Machine-generated algorithm that includes two fecal miRNAs (miR-421 and miR-27a-3p) and fecal hemoglobin concentration, along with age and gender- is more effective and cost-effective than FIT for the identification of patients with advanced colorectal neoplasm (i.e. colorectal cancer, advanced adenomas or advanced serrated lesions) among individuals participating in colorectal cancer screening and surveillance programs, and diagnosis.
Interventions
DIAGNOSTIC_TESTmiRFec test
The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Once the participant accepts to participate in the study, a fecal sample collection kit will be delivered together with the sample collection instructions. The sample must be collected at home before starting bowel preparation, more specifically between 24-72 hours before the day that colonoscopy is scheduled. Both miRNA expression and FIT will be analyzed in a central laboratory (Hospital Clinic of Barcelona) from the same fecal sample.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 50 to 75 (average-risk) referred to colonoscopy-based CRC screening. * Male or female aged 30 to 80 with family history of CRC (moderate-risk) referred to colonoscopy-based CRC screening. * Male and female aged 18 or older with personal history of colorectal polyps referred to colonoscopy surveillance. * Male and female aged 18 or older with personal history of CRC referred to colonoscopy surveillance. * Male and female aged 18 or older with colorectal symptoms referred to diagnostic colonoscopy.
Exclusion criteria
* Lack of informed consent to participate * Personal history of Lynch syndrome * Personal history of adenomatous or hamartomatous polyposis * Personal history of serrated polyposis syndrome * Personal history of inflammatory bowel disease * Personal history of total colectomy for any reason * Family history of Lynch syndrome * Family history of adenomatous or hamartomatous polyposis * Family history of serrated polyposis syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for advanced colorectal neoplasm | Through study completion, an average of 3 years | To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for colorectal cancer | Through study completion, an average of 3 years | To compare the sensitivity of the miRFec test with respect to FIT for the detection of colorectal cancer |
| Sensitivity for advanced adenomas | Through study completion, an average of 3 years | To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced adenomas |
| Sensitivity for advanced serrated lesions | Through study completion, an average of 3 years | To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced serrated lesions |
| Specificity | Through study completion, an average of 3 years | To compare the specificity of the miRFec test with respect to FIT |
| Discrimination capacity for advanced colorectal neoplasms | Through study completion, an average of 3 years | To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of advanced colorectal neoplasm |
| Discrimination capacity for colorectal cancer | Through study completion, an average of 3 years | To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of colorectal cancer |
| Cost-effectiveness for advanced colorectal neoplasm detection | Through study completion, an average of 3 years | To compare the cost (euros) for detecting one advanced colorectal neoplasm using the miRFec test with respect to the corresponding figure using FIT |
| Detection rate for advanced colorectal neoplasm | Through study completion, an average of 3 years | To compare the detection rate for advanced colorectal neoplasm of the miRFec test with respect to FIT |
Countries
Spain
Contacts
Primary ContactMireia Diaz
Outcome results
None listed