Distinct Metastatic Phenotypes Between Early-onset and La... | NCT06040021

Studies
Distinct Metastatic Phenotypes Between Early-onset and Late-onset Colorectal Cancer

NCT06040021

Sponsor

Fudan University

Status

Completed

Last Update Posted

Sep 15, 2023Actual

Enrollment

15,244Actual

Phase

Not provided

Conditions

Early-onset Colorectal Cancer
Late-onset Colorectal Cancer

Interventions

standardized treatment

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2008Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Sep 11, 2023

First Submission Date that Met QC Criteria

Sep 11, 2023

First Posted Date

Sep 15, 2023Actual

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

Sep 11, 2023

Last Update Posted Date

Sep 15, 2023Actual

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

The clinical and pathological features of early-onset colorectal cancer (EOCRC) differ from those of late-onset colorectal cancer (LOCRC). Our research aims to thoroughly elucidate the distinctions between them by analyzing clinical prognosis, metastatic patterns, gene expression, and genomic mutation profiles. Our deliberation will uncover latent strategies for personalized therapeutic of both EOCRC and LOCRC.

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

15,244Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
EOCRC	Patients aged<50 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.	Other: standardized treatment
IOCRC	Patients aged between 50 to 70 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.	Other: standardized treatment
LOCRC	Patients aged between≥70 with colorectal cancer between 2008 and 2018 in Fudan university Shanghai cancer center.	Other: standardized treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standardized treatment	Other	Patients enrolled in these 2 cohorts all received standardized treatment of colorectal cancer.	EOCRC IOCRC LOCRC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OS	overall survival	5 years after intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The initial diagnosis of colonoscopy and pathology belongs to colorectal cancer;
Patients should sign an informed consent form after fully understanding the purpose, procedures and potential risks of the study, indicating their voluntary participation in the research.

Exclusion Criteria:

Patients with obvious local or systemic severe infection;
Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation;
Have a systemic underlying disease that has not been controlled, or is unstable;
Patients with poor physical fitness or serious other organic diseases who cannot tolerate anesthesia and surgery;
Women during pregnancy, perinatal and lactation;
Patients with severe mental disorders (such as schizophrenia, bipolar disorder, etc.) or patients who are mentally incapable or unable to understand the requirements for participation in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

95 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with colorectal cancer hospitalized in Fudan university Shanghai cancer center.

Sampling Method

Non-Probability Sample