Journal of Clinical Trials
Open Access

Abstract

Pitfalls on Screening in Clinical Trials: Positive Pregnancy Test in a Nonpregnant Woman with Metastatic Breast Cancer

Edward Espinal, Maribel Palomero, María Cebollero, Sara Lopez-Tarruella, Yolanda Jerez, Santiago Lizarraga, Ivan Marquez-Rodas and Miguel Martín

We report on a rare case of a premenopausal female patient with metastatic breast cancer that was excluded from a clinical trial conducted in our institution after the detection of an elevated serum beta-hCG during the trial screening. Despite proving that the patient was not pregnant and that this serum beta-hCG elevation was a paraneoplastic phenomenon (tumor cells showed secretion of beta-hCG by IHC), the patient was ultimately excluded from trial entry. Some tumors, including breast cancer, can elevate serum beta-hCG as a paraneoplastic phenomenon, which sometimes correlates with prognosis in metastatic disease. We demonstrate through this case report that an elevated beta-hCG in a cancer patient is not always indicative of pregnancy, and that the possibility of a false positive result should be taken into account in clinical trial protocols as to avoid unnecessary exclusion of potential trial candidates.