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There were 1582 FNB procedures for metastatic melanoma with histologic verification or clinical follow-up.
Histologic verification of all lesions in stage 4 patients with metastases is impossible.
Immediately adjacent tissues were preserved in formalin for histologic verification of pathology.
In the dose-expansion phase, only patients with histologic verification of colorectal cancer were enrolled.
However, for stage 4 patients histologic verification of all metastases was impossible.
Moreover, due to ethical reasons, the histologic verification of metastasis was not performed for all distant lesions.
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The strengths of this study include the relatively large sample size, strict matching for area of residence to avoid possibility of confounding by region, verification of the reliability and validity of questionnaires, histologic confirmation of all case diagnoses, and appropriate sensitivity analyses.
These cases always require histologic confirmation.
One major point of weakness of the study is that no tissue biopsies were obtained for histologic examination and verification of tissue inflammation.
Histologic or functional verification of the response status would have been meaningful adjuncts to this study.
Because of the prolonged duration of the reactive stimulation experiments, necropsy tracts were visible on histologic section, which allowed verification of the stimulator wire insertion site.
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