Unknown,Transcriptomics,Genomics,Proteomics

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Microarray gene expression profiling of sorted CD8+ cells from individuals in the STAyCIS clinical trial

ABSTRACT: The STAyCIS trial is a randomized, double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of atorvastatin (Lipitor, Pfizer, 80mg/day) in patients with clinically isolated syndrome (a first demyelinating event) and at high risk of conversion to relapsing, remitting multiple sclerosis (RRMS). Samples were obtained from subjects in the STAyCIS study (NCT00094172) within a screening phase of 90 days from the index CIS event and followed up for 18 months (12 months treatment phase) with serial clinical and radiological (MRI imaging) review. The primary combined endpoint was the development of either radiological (>=3 new T2 MRI lesions) or clinical relapse (>=1 clinical exacerbation) during the 12 month treatment phase. Frozen, viable PBMC were stored before thawing and extraction of CD8+ cells by positive magnetic bead selection. RNA extracted from viable, purified CD8+ cells was labelled and hybridized to Affymetrix HuGene-1_0-st-v1 arrays.

ORGANISM(S): Homo sapiens

SUBMITTER: Eoin McKinney

PROVIDER: E-MTAB-9637 | biostudies-arrayexpress |

REPOSITORIES: biostudies-arrayexpress

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Project description:We report the results of a molecular study in thirty-seven cases of gliomatosis cerebri, correlating these results with prognosis. The well-known prognostic factors of gliomas, i.e., age, KPS, histology (Grade 2 vs. 3), or contrast enhancement, was predictive of response or outcome only in a percentage of patients but not in all patients. We identified an 8 miRNA signature able to predict patient prognosis with microarray gene expression profiling. The 8 gene features were used to built a prediction method able to distinguish patients with good prognosis (more likely to be responsive to therapy) from patients with a poor prognosis (less likely to be responsive to therapy). Keywords: miRNA expression profile Fifty-nine patients, between 12- and 73-years-old, with clinical signs of increased intracranial pressure were admitted to our institutions between January 2000 to September 2005. Pre-operative neuroradiological studies (CT scan and MRI) showed diffuse infiltrative processes involving more than two different lobes, no identifiable focal mass, and contrast enhancement absent or less than 1 cm in diameter. Written informed consent and tumour DNA were obtained for molecular analysis. Other eligibility criteria included a Karnofsky Performance Scale index (KPS) >50, normal bone marrow function (white blood cell count >3.0X109/l, neutrophil count >1.5X109/l, platelet count >100X109/l, and haemoglobin >10g/dL), normal liver function (aspartate aminotransferase or alanine aminotransferase <2 times the upper limit of laboratory normal, normal bilirubin, and alkaline phosphatase < 2 times the upper limit of normal), and normal renal function (serum creatinine <1.5 mg/dL). The patients received chemotherapy with temozolamide and radiotherapy. The TMZ schedule consisted of 150 to 200 mg/m2 was orally administered once daily on days 1 to 5. Treatment cycles were repeated every 28 days, with a maximum of 24 months. All patients had a monthly neurological and performance status evaluation and a radiological (MRI) evaluation every 2 to 3 months. Responses were evaluated according to previously described criteria (8): a clinical response was defined as an improvement of a neurological deficit or cognitive function evaluated by Mini-Mental Status Examination, an improvement of at least 75% in seizure frequency, or the disappearance of intracranial hypertension. When radiological MRI scans showed a reduction of more than 50% in the hyper intense area it was considered a partial response (PR), and a <50% regression or an objective regression of mass effect, was considered a minor response (MR). Disease was considered as stable when no clinical or radiological changes were seen for at least 6 months, whereas neurological deterioration, a need to increase corticosteroids, or evidence of tumour progression on MRI (an increase in the T2 or the appearance of contrast enhancement) indicated tumour progression.

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Microarray gene expression profiling of sorted CD8+ cells from individuals in the STAyCIS clinical trial

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