IRSN-23 Prospective Analyses
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ABSTRACT:
PROVIDER: PRJNA962905 | ENA |
REPOSITORIES: ENA
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Project description:PURPOSE: The IRSN-23 model uses DNA microarray analysis of tumor tissue to personalize patients into highly sensitive chemotherapy (Gp-R) or less sensitive (Gp-NR) based on the expression of immune-related genes. This study assessed the reproducibility of the IRSN-23 in prospective independent validation sets and investigated its clinical significance and impact on breast cancer subtype classification. METHODS: Tumour tissues were collected from 146 breast cancer patients undergoing preoperative chemotherapy (paclitaxel-FEC) ± trastuzumab in Osaka University Hospital (OUH). Patients were classified into Gp-R or Gp-NR using IRSN-23, and the model was examined for its ability to predict the pathological complete response (pCR). RESULTS: In the OUH prospective dataset, the pCR rate was significantly higher in the Gp-R group (29·3% (11/41)) than in the Gp-NR group (1·4% (1/71)) not using trastuzumab (P = 1·70E-5). CONCLUSION: This study provides prospective validation of the IRSN-23 in predicting chemotherapy efficacy, demonstrating a high degree of reproducibility.
2023-05-19 | GSE230881 | GEO
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Project description:Rationale: Throughout the years, there has been a rapid change in the perioperative protocols and procedures surrounding colorectal surgery. Upon the introduction of the Enhanced Recovery After Surgery (ERAS) program in Western countries, an improvement in postoperative outcomes was seen. Nowadays, researchers focus on further improving the current standard ERAS programs enabling an accelerated version hereof.
Objective: The aim of this study is to investigate the feasibility and safety of a 23-hour accelerated ERAS protocol (ERAS 2.0) for patients undergoing colorectal surgery compared to a retrospective cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS 2.0 protocol, patients undergoing colorectal surgery will be discharged within 23 hours after surgery.
Study design: This study is an investigator-initiated, single-center prospective study.
Study population: Patients aged ≥ 18 years ≤ 80 undergoing surgical resection for colorectal pathology that meet the eligibility criteria will be invited to participate in this study.
Intervention: Adhering to a strict multidisciplinary and multifaceted ERAS 2.0 protocol, patients receiving elective colorectal surgery will be discharged 23-hours after surgery.
Main study parameters/endpoints: Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery. Success rate will be measured in readmission rate and safety will be measured with rate of serious adverse events (Clavien Dindo ≥3b). Success rate (feasibility) will also be measured in percentage of patients who were not able to be discharged 23 hours after surgery.
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