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Clinical Chemistry 51: 113-118, 2005. First published November 11, 2004; 10.1373/clinchem.2004.039263
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(Clinical Chemistry. 2005;51:113-118.)
© 2005 American Association for Clinical Chemistry, Inc.

Cancer Diagnostics

Quantitative Analysis of Circulating Plasma DNA as a Tumor Marker in Thoracic Malignancies

Luis J. Herrera1, Siva Raja1, William E. Gooding2,3, Talal El-Hefnawy1, Lori Kelly1, James D. Luketich1,3 and Tony E. Godfrey1,3,a

1 Department of Surgery, University of Pittsburgh, Pittsburgh, PA.
2 Biostatistics Facility, University of Pittsburgh Cancer Institute, Pittsburgh, PA.
3 Pittsburgh Cancer Institute and Hillman Cancer Center, Pittsburgh, PA.

aAddress correspondence to this author at: Mount Sinai School of Medicine, One, Gustave L. Levy Place, Box 1079, New York, NY 10029. Fax 212-849-2523; e-mail tony.godfrey{at}mssm.edu.

Background: Increased plasma DNA has been found in cancer patients and may have potential as a tumor marker. The objectives of this study were to develop a controlled, quantitative PCR (QPCR) assay to measure plasma DNA and then evaluate plasma DNA concentrations as a tumor marker in patients with thoracic malignancies.

Methods: We developed a QPCR assay for DNA, using the human ß-actin gene. Plasma samples were analyzed from 58 patients with esophageal cancer (EC; 20 banked samples and 38 prospectively collected samples) and 25 patients with lung cancer (LC; all prospectively collected). Control groups consisting of 51 patients with gastroesophageal reflux disease (GERD; 23 banked samples and 28 prospectively collected) and 11 healthy volunteers were also analyzed.

Results: The assay had an experimental variability <4%. In our banked samples, the mean concentration of plasma DNA in EC was 819.0 µg/L (range, 46.2–4738.0 µg/L) vs 432.0 µg/L (6.0–2888.0 µg/L) in GERD (P = 0.02). However, the prospectively collected samples had lower DNA concentrations, and there was no difference between cancer patients and controls. The mean DNA concentration was 10.6 µg/L (range, 7.0–14.0 µg/L) in healthy volunteers and 10.5 µg/L (range, 4.0–23.5 µg/L) in GERD controls vs 13.0 µg/L (range, 4.5–46.5 µg/L) in EC and 14.6 µg/L (range, 3.0–30.0 µg/L) in LC.

Conclusions: Our data indicate that plasma DNA concentrations are of limited diagnostic value when samples are prospectively collected and uniformly handled. This is in contrast to previously published results. Qualitative analysis of DNA may be needed if plasma nucleic acids are to be used as a diagnostic tool in cancer screening.




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