Patient-derived Organoids Predicts the Clinical Efficienc... | NCT05183425

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

NCT05183425

Sponsor

Changhai Hospital

Status

Unknown status

Last Update Posted

Feb 4, 2022Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Explore the Consistency of Drug Sensitivity Between Primary Colorectal Cancer and Liver Metastases

Interventions

Not provided

Countries

China

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 26, 2021

First Submission Date that Met QC Criteria

Dec 26, 2021

First Posted Date

Jan 10, 2022Actual

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

Jan 22, 2022

Last Update Posted Date

Feb 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Zhang, Director of the department of colorectal surgery, Changhai HospitalPrincipal Investigator

Lead Sponsor

Changhai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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.

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

60Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

All patients with histologically proven colorectal cancer with liver metastasis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Colorectal Surgery in Changhai Hospital	Recruiting	Shanghai	Shanghai Municipality	200433	China