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Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials

ABSTRACT: Background: Inadequate representation of elderly cancer patients in randomized clinical trials (RCTs) leading to a lack of external validity thereby an uncertainty regarding benefit-risk balance of cancer treatment in elderly, especially chemotherapy. Hypothesis: The eligibility criteria explain only a part of the under-representation of elderly patients in trials. We make the assumptions that 1) Among the eligible, the invitation to participate in a trial and inclusion are inversely related to age, 2) Among the eligible, there are patients, practitioner, or organization factors that would explain the non inclusion of elderly patients. Objectives: 1) To assess, in elderly patients with colorectal cancer, the proportions of patients: 1. eligible at least to one RCT 2. invited to participate 3. included 2) a) Compare proportions among elderly patients to those of the comparator group of "young" subjects (age ≥ 18 and <65 years) (added by amendment n°3 accepted 18/02/2014) b)To identify factors associated with the non-invitation and the non-inclusion in RCT. Material and methods: Study design: A multicentric prospective cohort survey Population: all patients aged 18 years or more (added by amendment n°3 - 02/2014) with a colorectal cancer followed in one of the participating centers. Data collection: * At baseline: Patient characteristics (including SOCIO-demographic, oncologic and geriatric data) will be collected. Organization factors (e.g. clinical research team) will be collected. * Follow-up: the patient will be followed for potential invitation and inclusion in one RCT. Reasons of non-invitation or non-inclusion will be assessed. Number of subjects needed: 696 (553 elderly patients and 143 "young" patients) Number of centers : 7 (added by amendment n°3 - 02/2014) Ethical aspects: each patient will give his oral informed consent. The International Review Board of Mondor Hospital (CPP Ile-de-France IX) gave its approval in December 2012.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2137241 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background Rotator cuff tears (RCT) is a common musculoskeletal disorder in the shoulder which cause pain and functional disability. Diabetes mellitus (DM) is characterized by impaired ability of producing or responding to insulin and has been reported to act as a risk factor of the progression of rotator cuff tendinopathy and tear. Long non-coding RNAs (lncRNAs) are involved in the development of various diseases, but little is known about their potential roles involved in RCT of diabetic patients. Methods RNA-Sequencing (RNA-Seq) was used in this study to profile differentially expressed lncRNAs and mRNAs in RCT samples between 3 diabetic and 3 nondiabetic patients. Gene ontology (GO) and Kyoto encyclopedia of genes and genomes (KEGG) pathway analysis were performed to annotate the function of the differentially expressed genes (DEGs). LncRNA-mRNA co-expression network and competing endogenous RNA (ceRNA) network were constructed to elucidate the potential molecular mechanisms of DM affecting RCT. Results In total, 505 lncRNAs and 388 mRNAs were detected to be differentially expressed in RCT samples between diabetic and nondiabetic patients. GO functional analysis indicated that related lncRNAs and mRNAs were involved in metabolic process, immune system process and others. KEGG pathway analysis indicated that related mRNAs were involved in ferroptosis, PI3K-Akt signaling pathway, Wnt signaling pathway, JAK-STAT signaling pathway and IL-17 signaling pathway and others. LncRNA-mRNA co-expression network was constructed, and ceRNA network showed the interaction of differentially expressed RNAs, comprising 5 lncRNAs, 2 mRNAs, and 142 miRNAs. TF regulation analysis revealed that STAT affected the progression of RCT by regulating the apoptosis pathway in diabetic patients. Conclusions We preliminarily dissected the differential expression profile of lncRNAs and mRNAs in torn rotator cuff tendon between diabetic and nondiabetic patients. And the bioinformatic analysis suggested some important RNAs and signaling pathways regarding inflammation and apoptosis were involved in diabetic RCT. Our findings offer a new perspective on the association between DM and progression of RCT.

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Inclusion of Elderly Patients With Colorectal Cancer in Clinical Trials

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