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An investigator-initiated trial to investigate the utility of LUNAR-1 in colorectal cancer patients with resectable distant metastases

ABSTRACT: Interventions: ctDNA test using LUNAR-1 Blood samples will be taken before surgery (in the case of a two-step surgery, before surgery for metastatic lesions), 28 days after surgery, 12, 24, 36, 48, 60, 72, 84, 96 weeks after surgery. The amount of blood will be 10 mL per test tube, and 4 test tubes will be collected. postoperative adjuvant therapy If the ctDNA test result is negative at 28 days after surgery, postoperative adjuvant therapy will not be administered.;D011379;ctDNA, Adjuvant chemotherapy Primary outcome(s): 1) Negative predictive value in ctDNA-negative patients at 28 days postoperatively. 2) Positive predictive value of ctDNA for recurrence during the postoperative observation period Study Design: single arm study, open(masking not used), historical control, single assignment, screening

DISEASE(S): Patients Scheduled For Curative Resection For Metastasis Of Colorectal Cancer,Ctdna, Colorectal Cancer, Oligometastasis

PROVIDER: 78961 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Treatment options and reliable predictive marker to determine patients at risk to develop postoperative LD and to define the optimal time point of liver resection are limited. Accordingly, there is an urgent need for an easily assessable preoperative test to predict postoperative liver function recovery, specifically as current markers are often expensive, time consuming and sometimes invasive. Emerging evidence suggests that microRNA (miRNA) signatures represent potent diagnostic, prognostic and treatment response biomarkers for several diseases. Using next-generation sequencing as an unbiased systematic approach 554 miRNAs were detected in preoperative plasma of 21 patients suffering from postoperative LD after liver resection and 27 matched controls. Subsequently, we identified a miRNA signature - consisting of miRNAs 151a-5p, 192-5p and 122-5p - that highly correlated with patients developing postoperative LD after liver resection. The predictive potential for postoperative LD was subsequently confirmed using real-time PCR in an independent validation cohort of 98 patients. Ultimately, a regression model of the two miRNA ratios 151a-5p to 192-5p and 122-5p to 151a-5p was found to reliably predict postoperative LD, severe morbidity, prolonged intensive care unit and hospital stay and even mortality prior to surgery with a remarkable accuracy, thereby outperforming established markers of postoperative LD. Ultimately, we documented that miRNA ratios closely followed liver function recovery after partial hepatectomy. Conclusion: Given the clinical relevance of predicting potentially fatal postoperative clinical outcome after liver resection, our data demonstrate the clinical utility of a novel miRNA-based biomarker to support the selection of patients undergoing partial hepatectomy. The dynamical changes during liver function recovery indicate a possible role in tailoring the optimal time point of surgery to each individual patient. Thereby, our data might help to tailor surgical strategies to the specific risk profile of individual patients.

Dataset Information

An investigator-initiated trial to investigate the utility of LUNAR-1 in colorectal cancer patients with resectable distant metastases

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