Reverse transcriptase polymerase chain reaction (RT-PCR)based assays t
o detect occult neoplastic cells offer the highest sensitivity for the
study of tumour dissemination and minimal residual disease. The detec
tion of small numbers of tumour cells in a clinical sample may result
in a redefinition of what constitutes residual disease and relapse, af
fecting future patient management. However, there remains disparity in
the published data on the clinical value of RT-PCR for the detection
of circulating tumour cells. This most likely reflects differences in
the methods for sample preparation, RNA extraction, and cDNA synthesis
among laboratories. Consequently the need for implementation of stand
ard quality control measures is pressing in order to facilitate meanin
gful assessment of the methodology and it's clinical value. A 5-day wo
rkshop organized by the immunotherapy subgroup of the EORTC Melanoma C
ooperative Group was held on this topic at the Ludwig Institute in Epa
linges-sur-Lausanne, Switzerland in January 1996, with Stefan Carrel a
s the local host. Many pertinent issues were discussed in great detail
, covering every step from sample handling to quality control. This wo
rkshop resulted in a concerted action leading to the preparation of la
boratory guidelines, which are summarized in this review.