NCT04525807

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 21, 2020

Last Update Submit

August 24, 2020

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • progression-free survival

    1 year

  • Overall survival

    3 years

Study Arms (1)

Multiomics arm

Guide therapy based on multi-omics

Diagnostic Test: Multi-omics

Interventions

Multi-omicsDIAGNOSTIC_TEST

Use multi-omics to analyze

Multiomics arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 25, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share