Abstract
ObjectiveTo establish the sensitivity and specificity of a human papillomavirus (HPV) and tumor marker DNA/mRNA assay for detecting cervical cancer that is transferrable to a Lab-on-a-chip platform and determine its diagnostic benefit in early stage disease when used in conjunction with high-resolution endovaginal magnetic resonance imaging (MRI).MethodsForty-one patients (27 with Stage1 cervical cancer [Group1] and 14 non-cancer HPV negative controls [Group2]) had DNA and RNA extracted from cervical cytology swab samples. HPV16, HPV18, hTERT, TERC/GAPDH and MYC/GAPDH concentration was established using a loop mediated isothermal amplification (LAMP) assay. Thresholds for tumor marker detection for Group1 were set from Group2 analysis (any hTERT, TERC/GAPDH 3.12, MYC/GAPDH 0.155). Group 1 participants underwent endovaginal MRI. Sensitivity and specificity for cancer detection by LAMP and MRI individually and combined was documented by comparison to pathology.ResultsSensitivity and specificity for cancer detection was 68.8% and 77.8% if any tumor marker was positive regardless of HPV status (scenario1), and 93.8% and 55.8% if tumor marker or HPV were positive (scenario 2). Adding endovaginal MRI improved specificity to 88.9% in scenario 1 (sensitivity 68.8%) and to 77.8%% in scenario2 (sensitivity 93.8%).ConclusionSpecificity for cervical cancer detection using a LAMP assay is superior with tumor markers; low sensitivity is improved by HPV detection. Accuracy for early stage cervical cancer detection is optimal using a spatially multiplexed tumor marker/HPV LAMP assay together with endovaginal MRI.
Highlights
Treatment of cervical intraepithelial neoplasia at colposcopy with cold knife cone (CKC) biopsy or large loop excision of the transformation zone (LLETZ) can sometime excise a small volume cervical cancer
Forty-one patients (27 with Stage1 cervical cancer [Group1] and 14 noncancer human papillomavirus (HPV) negative controls [Group2]) had DNA and RNA extracted from cervical cytology swab samples
Specificity for cervical cancer detection using a loop mediated isothermal amplification (LAMP) assay is superior with tumor markers; low sensitivity is improved by HPV detection
Summary
Treatment of cervical intraepithelial neoplasia at colposcopy with cold knife cone (CKC) biopsy or large loop excision of the transformation zone (LLETZ) can sometime excise a small volume cervical cancer. Defining the presence and extent of any residual disease crucially determines subsequent surgical management [1]. As women being treated for cervical precancer or early cancer are of similar age to women having their first child, fertility and reproductive effects of local excision of disease are important. Increasing evidence suggests that the amount of cervical tissue excised or destroyed, measured as the cone length in excisional techniques, is a predictor for subsequent obstetric risk [4, 5]. A larger amount of residual cervical tissue detected on scan after treatment for both dysplasia and cancer is associated with improved obstetric outcomes [6,7,8]. It is critical to balance risk related to oncological versus reproductive outcomes by enabling the optimal local excisional treatment for these women
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