Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory

In order to more accurately discover the cause of drug resistance in tumor treatment, and to provide a new basis for precise treatment.

Therefore, based on the umbrella theory of precision medicine, we carried out this single-center, prospective, and observational study to include patients with liver metastases from colorectal cancer. By combining genome, transcriptome, and proteomic sequencing data, we established a basis for colorectal cancer liver Transfer the multi-omics data of the sample, describe the reason for the resistance of the first-line treatment, and search for new therapeutic targets.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Diagnostic test: Multi-omics

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were newly diagnosed with liver metastases from colorectal cancer (pathologically diagnosed as adenocarcinoma)

Description

Inclusion Criteria:

• ECOG score 0-2 points
• Pathologically diagnosed patients with colorectal cancer
• Combined with liver metastases confirmed by imaging, and the lesion is measurable (RECIST standard)
• The lesion is available
• First-line treatment failed; hematology, liver and kidney function tests are suitable for back-line treatment
• Informed consent

Exclusion Criteria:

• With brain metastases
• History of other malignancies
• Pregnancy or breastfeeding
• Have received other drug clinical studies within 30 days before the start of this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiomics arm; Guide therapy based on multi-omics	Diagnostic test: Multi-omics; Use multi-omics to analyze

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete remission (CR) and partial remission (PR) cases	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	Refers to the date from initial diagnosis to tumor progression	1 year
Overall survival	Refers to the date from initial diagnosis to last follow-up or death date	3 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2020-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No