Patient-derived Organoids Predicts the Clinical Efficiency of Colorectal Liver Metastasis

January 22, 2022 updated by: Wei Zhang, Changhai Hospital

The Exploratory Study of Patient-derived Organoids for the Prediction and Evaluation of Clinical Efficiency Effect of Colorectal Cancer Liver Metastasis

Accumulating evidence indicates that patient- derived organoids (PDOs) can predict drug responses in the clinic. Metastasis is the main cause of death in colorectal cancer patients, and the treatment of patients with liver metastasis remains poor. Tumor heterogeneity is the cause of treatment failure. In this study, we aim the investigate the consistency of drug sensitivity for the matched primary and metastatic tumor in patients with liver metastasis.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Department of Colorectal Surgery in Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

All patients with histologically proven colorectal cancer with liver metastasis.

Description

Inclusion Criteria:

  • Histologically proven colorectal cancer with liver metastasis
  • Aged between 18 and 70 years
  • Written informed and signed consent
  • Accessible to surgery sample of metastasis and primary tumor

Exclusion Criteria:

  • Less than 18 years and older than 70 years
  • Not able to give informed consent
  • Not accessible to surgery sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The consistency of drug sensitivity
Time Frame: 3 years
To test the consistency of drug sensitivity of primary tumor and its matched liver metastasis
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The establishment of PDO
Time Frame: 3 years
To test the rate of PDO derived from primary and matched metastatic colorectal cancer .
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 26, 2021

First Submitted That Met QC Criteria

December 26, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHCS-PDO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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