The proposed study aims to validate the diagnostic value of a panel of serum antibodies for the early detection of colorectal cancer (CRC). We have developed a serum antibody based assay that shows promise in discriminating sera from CRC patients from healthy donors. We have evaluated two separate sample sets of sera that were available either commercially or were comprised of left over samples from previous studies by our group. Both sample sets showed concordance in discriminatory power. We have not been able to identify investigators with a larger, well defined sample set of early stage colon cancer sera and request assistance from the EDRN in obtaining such samples to help assess the potential diagnostic value of our autoantibody panel
To validate the diagnostic value of a panel of serum antibodies (cathepsin D, p53, cyclin B1, topoisomerase IIalpha, IGFBP2, CEA) for the early detection of colorectal cancer.
We will run ELISA blinded to case status, data along with our prediction of disease status for each sample, will be sent to EDRN-DMCC at Fred Hutchinson Cancer Research Center for statistical analysis. DMCC already has the combination role from our preliminary study. Our preliminary data suggested that at high specificity 90%, sensitivity is 57%. With n=50 in each group, we have more than 80% power to confirm this level of sensitivity against an inferior sensitivity of 37% at 90% specificity comparing CRC versus normal controls. We understand that the reference set is not powered for definitive validation but to help prioritization. We did not have the data on patients with adenoma but the performance on early-stage CRC suggests that it is possible our marker panel could detection early lesions like adenoma,
Goodell V, Lu H, Delong J, Disis ML. Antibody Immunity to a Panel of Oncogenic Proteins May Predict Presence of Colorectal Cancer and Stage of Disease. Manuscript in preparation.
There are currently no biomarkers annotated for this protocol.
No datasets are currently associated with this protocol.