Review Article
Early Detection Biomarkers for Ovarian Cancer
Table 2
Clinical trials (currently active or completed) for evaluating novel biomarkers of ovarian cancer.
| | Biomarker | Clinical trials for evaluating early detection biomarkers in ovarian cancer (USA) | | Condition | Phase | n | Status | Clinical trial no. | Reference | Primary outcome measure |
| | All biomarkers | Adnexal mass | 1 | 500 (E) | Not yet recruiting | NCT01466049 | NA | Screening | | HE4 + CA125 | Pelvic mass | 0 | 566 | Completed | NCT00315692 | [23] | cancer versus benign disease | | CA125 | Low risk (w) | 1 | 9500 (E) | Recruiting | NCT00539162 | NA | Rate of increase in CA125 over time | | HE4 + CA125 | Adnexal mass | 1 | 512 | Completed | NCT00987649 | NA | Initial cancer risk assessment | | CA125 + HE4 | High risk (w) | 1 | 1208 (E) | Recruiting | NCT01121640 | NA | PPV of screening protocols | | CA125 | High risk (w) | 2 | 2400 (E) | Unknown | NCT00080639 | NA | Screening | | Mesothelin | Low risk (w) | 0 | 250 (E) | Unknown | NCT000155740 | NA | Screening | | FOLR1 | Stage I Ov ca. | 2 | 50 (E) | Recruiting | NCT01511055 | NA | Sensitivity and specificity of IOI with folate | | CA125 + TVU | Ovarian diseases | 0 | 750 (E) | Recruiting | NCT01292733 | NA | CA125 measurement in blood over time | | CA125 ± TVU | Postmenopausal | 0 | 48230 | Completed | NCT00058032 | [24, 25] | Screening postmenopausal women | | CA125 | High risk (w) | 0 | 2430 | Recruiting | NCT00039559 | NA | Feasibility at study completion | | CA125 + TVU | High genetic risk (w) | 0 | 5000 (E) | Unknown | NCT00033488 | NA | Annual screening | | CA125 | High risk (w) | 0 | 6000 (E) | Recruiting | NCT00005095 | NA | Screening | | Combined methods | Ov. neoplasms | 0 | 36000 | Not yet recruiting | NCT01178736 | NA | Low-cost screening | | Interventional | High risk (w) | 0 | 1500 | Recruiting | NCT00849199 | NA | Genetic testing, screening | | All Biomarkers | High risk (w) | 0 | 250 (E) | Recruiting | NCT00854399 | NA | Overall survival | | Tumor markers | High risk (w) | 0 | 5000 | Completed | NCT00267072 | NA | Early stage detection | | DNA markers | Ovarian cancer | 0 | 170 (E) | Recruiting | NCT00879840 | NA | Assessment of screening modalities | | BRCA 1/2 mutation | Ov. neoplasms | 0 | 1500 | Completed | NCT00001468 | NA | Identifying BRCA 1/2 mutation |
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TVU: transvaginal ultrasonography. (w): women, (E): estimated enrollment, IOI: intraoperative imaging. Source: http://clinicaltrials.gov/.
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