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A placebo versus study medication trial study for verification of improving survival in metastatic colorectal cancer patients.

ABSTRACT: Interventions: Clinical safety/efficacy, randomized, double-blinded, phase 3 trial of placebo versus xilonix. It will be included 800 patients of both sexes aged 18 years or older. Patients will receive 1 dose every 2 weeks of placebo (1/3 of patients) or of 7,5 mg/kg of the human monoclonal antibody anti interleukin 1a (also named MABp1 or xilonix) that will be administered intravenously for as long as the patient is beneficiating or until he/she reaches any of the protocol discontinuation criteria, i.e: pregnancy, consent withdrawal, disease progression, adverse event that justifies the patient withdrawal or study termination by the sponsor.;Drug;Biological/vaccine Primary outcome(s): Overall survival will be the primary endpoint of this study survival time will be defined as the duration from the date of randomization until death or censor date. Study Design: Clinical trial of efficacy, randomized, double-blinded, double arm and placebo-controlled (1:2), phase 3

DISEASE(S): Metastatic Colorectal Cancer Patients

PROVIDER: 2558266 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:The effect of pre and periconceptional multiple micronutrient supplementation on methylation of CpG loci within CpG islands associated with 14,000 genes across the human genome has been investigated in the offspring of a cohort of Gambian women participating in a controlled double blinded trial. Methylation levels in placebo and micronutrient supplemented cohorts were compared in genomic DNA from cord blood (35 placebo and 21 micronutrient supplemented) and in circulating blood samples (14 placebo and 9 micronutrient supplemented) drawn from the same cohort at 9 months old. A small number of differentially methylated CpG loci were identified in cord blood (14 in males and 21 in females) and a larger number in the 9 month infant comparison (108 in males and 106 in females). Seven differentially methylated loci in males and 8 in females persisted from cord to infant. These findings indicate that micronutrient supplementation pre-conception or early in embryonic development is potentially associated with programming of gene activity at birth, which is maintained into early infanthood. Strikingly, the loci affected by micronutrient supplementation differed between males and females, with no shared changes in cord blood and only 5 shared changes at 9 months. Additionally, a large number of CpG loci showed variation in methylation level when comparing 9-month samples to cord blood samples. These postnatal changes were more consistent between sexes, with 85% of female alterations being found as a subset of male changes in the placebo cohort and 62% of the female changes shared with males in the supplemented cohort. Taken together, the results suggest that there is a core developmental program shared between the sexes that is unaffected by nutrient supplementation, but that there are also sex-specific developmental changes which are altered under conditions of micronutrient supplementation and deficiency. Bisulphite converted DNA from 59 cord (36 placebo and 23 treated) and 25 infant peripheral blood (15 placebo and 10 treated) samples were hybridised to the Illumina Infinium 27k Human Methylation Beadchip v1.2. (For further analysis, five were excluded during quality control leaving 56 cord (35 placebo and 21 treated) and 23 infant peripheral blood (14 placebo and 9 treated) samples. Full data set of 84 samples were submitted to GEO)

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A placebo versus study medication trial study for verification of improving survival in metastatic colorectal cancer patients.

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