The validity of a 77-item food-frequency questionnaire (FFQ) developed for a multicenter case-control study on diet and cancer in Italy was assessed. Trained interviewers administered the same FFQ to 452 volunteers from three Italian provinces (Pordenone, Genoa, and Forli) completed in two different seasons, at an interval of 3 to 10 months. For 395 (130 males, 265 females; median age = 52 years; range = 35 to 69 years) volunteers, two 7-day dietary (7-DD) records were available. Average intake obtained by means of the FFQ was overestimated by approximately 18% in comparison with the corresponding values based on the two 7-DD records (reference method). Pearson partial correlation coefficients, adjusted for total energy intake between the nutrient intakes assessed by the FFQ and reference method, ranged from 0.19 for vegetable fat to 0.64 for sugar (median value r = 0.46). The unadjusted deattenuated coefficients, which took into account the interindividual variability of consumption, estimated by means of the two 7-DD records, ranged from 0.29 for vegetable fat to 0.72 for starch (median value r = 0.54). The proportion of subjects correctly classified within the lowest two quintiles ranged between 59% for vegetable fat and vitamin E, and 96% for alcohol, and those correctly classified within the highest two quintiles ranged between 44% for vegetable fat and 94% for alcohol. The average proportion of subjects correctly classified within one quintile was 73%. These data indicate that this FFQ provides valid estimates of intakes for major nutrients, comparable to those reported from other studies in North America and other European countries.