Precision Medicine for Colorectal Cancer Liver Metastasis... | NCT04525807

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

NCT04525807

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Aug 25, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Colorectal Cancer Metastatic

Interventions

Multi-omics

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Sep 1, 2022Estimated

First Submitted Date

Aug 21, 2020

First Submission Date that Met QC Criteria

Aug 24, 2020

First Posted Date

Aug 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2020

Last Update Posted Date

Aug 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiomics arm		Guide therapy based on multi-omics	Diagnostic Test: Multi-omics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-omics	Diagnostic Test	Use multi-omics to analyze	Multiomics arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided