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Page 22 of 27 J Cancer Metastasis Treat 2019;5:5 I http://dx.doi.org/10.20517/2394-4722.2018.108

coated slide that quickly immobilizes living nucleated cells, thus avoiding pre-selection and any change in
cell structure and biology.

Experimental model: Twenty-two patients undergoing surgical lung resection have been included in the
preliminary study. Blood sample was collected from patients and the white blood cells fraction was let adhere
on SBS-CTC slide. The cells were stained with anti-CD45 and anti-pan-CK antibodies. Positive cells (putative
CTCs) were detected with an automated fluorescence microscope, isolated by laser capture microdissection
and characterized for gene mutations.

Results: All patients were positive for at least 1 epithelial cell (putative CTC)/mL of blood, though no
correlation between the number of epithelial cells and the stage of the disease was observed. NGS analysis
revealed gene variants associated with tumors in all patients, of whom 13 patients had mutations in genes
that are specifically associated with lung cancer. One patient carries BRAF V600E mutation, that has been
identified also in the tissue biopsy.

Conclusion: Epithelial cells are present in the blood of lung cancer patients. Further analyses of the genotype
and phenotype are in the process to determine whether these cells are indeed CTSs.

30. Benefit sharing and globalisation of industry sponsored clinical trials for breast cancer
research

Anil Babu Payedimarri, Gianluca Gaidano

Department of Translational Medicine, University of Eastern Piedmont, Novara 28100, Italy.

Introduction: The burden of cancer is the greatest and rising most rapidly in low-income and middle-income
countries (LMICs). The survival of breast cancer is especially poor in LMICs due to late stage presentation
and inadequate access to therapy. Whereas low-income countries (LICs) suffer from a generalized lack of
access to cancer care, in middle-income countries (MICs) such services and facilities may exist. However,
highly-priced innovative medicines are often only affordable for certain subsets of the population, and good
outcomes remain biased toward those who can pay. We carried out comprehensive analysis of the geographic
distribution of breast cancer clinical trials involving at least one LMICs clinical site and trials evaluating
costly innovative medicines.

Methodology: Data were extracted from clinicaltrials.gov registry (as of 30 Jun 2018). Advanced search
filters used: (1) condition/disease: breast cancer; (2) study type: Interventional studies; (3) phases: I to IV; (4)
funder type: industry. Countries were classified by income according to the World Bank (Fiscal year 2019).

Results: We analysed 1,746 trials. The fraction of phase III trials involving MICs sites was 55.36% (155/280)
in which Lower-MICs (L-MICs) were 27.14% (76/280) and Upper-MICs (UMICs) were 54.64% (153/280).
Smaller proportions of Phase I and II trials were conducted in MICs i.e. 5.92% (26/439) and 16.23% (161/992).
Phase IV trials that involve MICs were 31.43% (11/35). No trials were conducted in LICs. L-MICs countries
with the highest number of trials were India (n = 63) and Ukraine (n = 56) followed by Philippines (n = 23),
Egypt (n = 17), and Pakistan (n = 10). For U-MICs, Russian Federation (n = 141), Brazil (n = 113), China (n =
112), followed by Mexico (n = 88) and Turkey (n = 66).

Conclusion: Our analysis of the case of industry sponsored clinical trials with new, innovative medicines
for breast cancer confirms previous observations with rarer blood cancers, that such trials are increasingly