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An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)

ABSTRACT: This prospective, multicenter, observational study will investigate the effectiveness and safety of bevacizumab in routine clinical practice in participants with metastatic CRC. Participants are to have initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to the bevacizumab Summary of Product Characteristics (SmPC).

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2179410 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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An Observational Study of First-Line Bevacizumab (Avastin) With Fluoropyrimidine-Based Chemotherapy in Participants With Metastatic Colorectal Cancer

Project description:This multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.

| 2134002 | ecrin-mdr-crc

An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer in Italy (BEWARE)

Project description:This observational, multicenter, retrospective/prospective study will evaluate the use of Avastin (bevacizumab) in clinical practice in patients with metastatic colorectal cancer. Patients having initiated first-line treatment with a fluoropyrimidine-based chemotherapy and Avastin will be followed for up to 15 months.

| 2126159 | ecrin-mdr-crc

Transcriptomic profiling of RV144 trial participants

Project description:Transcriptomic profiling of RV144 trial participants

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DNA methylation in PREDIMED-Navarra participants

Project description:DNA methylation in PREDIMED-Navarra participants

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TAS-102, Irinotecan, and Bevacizumab in Pre-treated Metastatic Colorectal Cancer (TABAsCO), A Phase II Clinical Trial. ClinicalTrials.gov NCT04109924

Project description:Background: The efficacy of FOLFIRI plus an antiangiogenesis biologic agent as 2nd line therapy for metastatic colorectal adenocarcinoma is limited. TAS-102 is a novel oral antimetabolite with a distinct mechanism of action from fluoropyrimidines. We evaluated the antitumor efficacy of TAS-102, irinotecan and bevacizumab in patients with pre-treated, advanced colorectal adenocarcinoma in a multicenter, phase II, single-arm study. Methods: Patients with advanced colorectal adenocarcinoma who had progressed after oxaliplatin and fluoropyrimidine and were eligible for treatment with bevacizumab were treated with irinotecan, bevacizumab, and TAS-102 in 28-day cycles. The primary endpoint was progression-free survival (PFS). Results: We enrolled 35 evaluable patients. The study was positive. The median PFS was 7.9 (90% CI 6.2-11.8) months (vs. 6 months in historical control, p=0.018). The median overall survival was 16.5 (90% CI 9.8-17.5) months. Sixty-seven percent of patients experienced grade 3 or higher treatment-related adverse events. The most common toxicities were hematological (neutropenia) and gastrointestinal (diarrhea, nausea, and vomiting). Conclusions: Irinotecan, TAS-102 and bevacizumab is an active 2nd line therapy for patients with metastatic colorectal adenocarcinoma. Neutropenia is common and can affect dose density/intensity mandating use of G-CSF. A randomized study versus standard of care therapy is warranted.

2024-08-26 | GSE275628 | GEO

Longitudinal gene expression profiling of self-collected blood samples in COVID-19+ and healthy participants

Project description:Longitudinal cohort: 773 host response genes were profiled in previously vaccinated (n=16) and unvaccinated (n=14) COVID-19+ participants along with 5 healthy uninfected controls across a 2-week observational window Single timepoint cohort: 773 host response genes were profiled in 6 healthy uninfected participants

2023-09-30 | GSE243348 | GEO

Evaluating the utility of proteomics for the identification of circulating pharmacodynamic biomarkers of IFNβ-1 biologics

Project description:In this study, we evaluated the utility of proteomics to identify plasma proteins in healthy participants from a phase I clinical trial with IFNβ-1a and pegIFNβ-1a biologics to identify potential pharmacodynamic (PD) biomarkers. Using a linear mixed-effects model with repeated measurement for product-time interaction, we found that 248 and 528 analytes detected by the SOMAscan® assay were differentially expressed (p-value < 6.86E-06) between therapeutic doses of IFNβ-1a or pegIFNβ-1a, and placebo, respectively. We further prioritized signals based on peak change, area under the effect curve over the study duration, and overlap in signals from the two products. Analysis of prioritized datasets indicated activation of IFNB1 signaling and an IFNB signaling node with IL-6 as upstream regulators of the plasma protein patterns from both products. Increased TNF, IL-1B, IFNG, and IFNA signaling also occurred early in response to each product suggesting a direct link between each product and these upstream regulators. In summary, we identified longitudinal global PD changes in a large array of new and previously reported circulating proteins in healthy participants treated with IFNβ-1a and pegIFNβ-1a that may help identify novel single proteomic PD biomarkers and/or composite PD biomarker signatures as well as provide insight into the mechanism of action of these products. Independent replication is needed to confirm present proteomic results and to support further investigation of the identified candidate PD biomarkers for biosimilar product development.

2023-10-31 | GSE207945 | GEO

A Study of Bevacizumab Plus 5-Flurouracil (5-FU) Based Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer

Project description:This open-label, single arm, multicenter study evaluated the resection rate in participants with colorectal cancer and previously untreated unresectable liver-only metastases after adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting. Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively, unless they experienced progressive disease or unacceptable toxicity.

| 2132731 | ecrin-mdr-crc

Methylation profiling by array of subcutaneous fat derived from 856 TwinsUK participants

Project description:Epigenetic changes such as DNA methylation variation are known to play a role in gene regulation and common disease susceptibility. Little is known about the genome-wide frequency, localization and function of such changes and how they are regulated by genetic and environmental factors. We have utilized the MuTHER resource and generated methylation profiles across multiple tissues conducted in a large set of female individuals that allows systematic dissection of genetic and non-genetic effects on DNA methylation. DNA methylation was quantified in subcutaneous fat and skin derived from 648 TwinsUK participants using the Infinium HumanMethylation450 BeadChips. Data from transcription profiling of skin, adipose fat and lymphoblastoid cell lines (LCLs) from the same set of TwinsUK participants have been deposited in ArrayExpress under accession number E-TABM-1140 (https://www.ebi.ac.uk/arrayexpress/experiments/E-TABM-1140).

2013-10-01 | E-MTAB-1866 | biostudies-arrayexpress

Single-nucleus RNA sequencing of human subcutaneous adipose tissue biopsies from 16 Finnish participants.

Project description:Single-nucleus RNA-seq was performed to characterize the transcriptomes of cell types in human subcutaneous adipose tissue. Biopsies from 16 Finnish participants from the Finnish Twin Study and CRYO study were included.

2023-07-22 | GSE236708 | GEO

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