Toward a laboratory data interchange standard for clinical trials.

A subsequent literature search revealed one study pertaining to CA-125 in HF patients. That study included 71 patients of all New York Heart Association (NYHA) classes and showed a relationship between advancing HF and progressive increases in CA-125 concentrations [mean CA-125 for NYHA classes: class I ϭ 36 units/mL; class II ϭ 79 units/mL; class III ϭ 210 units/mL; class IV ϭ 502 units/mL (4)]. The authors of this study felt that the elaboration of CA-125 could be from the pericardial mesothelium; however, the exact mechanism is unclear (4 –7). In clinical practice, augmentation of HF therapy is based solely on worsening symptoms and echocardiographic findings. However , on the basis of this initial encouraging report and our experience, this pilot study investigated the possibility of using the CA-125 marker to identify patients with worsening HF before they develop clinical symptomatology. We analyzed serum CA-125 concentrations using the CENTOCOR CA-125 II RIA from blood obtained during a 6-month period from 35 patients (33 males; 30 Caucasians) with NYHA class III or IV HF awaiting cardiac transplantation. Blood was drawn during their routine clinic visits and while they were hospitalized. This study was approved by the Institutional Review Board, and informed consent was obtained from all patients. Clinical stability was based on examination by a HF cardiologist, as well as invasive hemodynamic measurements. Patients with markedly abnormal hemodynamics, or those with signs of low output failure, were considered unstable. Although many of the patients did show increases in CA-125 concentrations, some being quite marked, there was no correlation between clinical status and the concentration of CA-125 (Table 1). There was also no correlation between " confounding " factors, such as pericardial, pleural, or peritoneal effusions. We were unable to confirm the published correlation and conclude that CA-125 is not a useful marker in predicting cardiac status or managing pretransplant patients. However, perhaps a larger and longer-term study may be able to show a meaningful relationship. A radioimmunoassay using a monoclonal antibody to monitor the course of epithelial ovarian cancer. mesothelial cells are more potent than ovarian cancer cells in producing tumor marker CA-125. To the Editor: In 2001, an estimated 2.3 million people in the United States participated in and completed a clinical trial: 750 000 in government-sponsored clinical trials, 850 000 in industry-sponsored Phase I to III clinical trials, and 700 000 in industry sponsored Phase IV clinical trials (1). …