Second Primary Cancer and Early-onset Colorectal Cancer | NCT06423924

Studies
Second Primary Cancer and Early-onset Colorectal Cancer

NCT06423924

Sponsor

LI XIN-XIANG

Status

Unknown status

Last Update Posted

May 21, 2024Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Colorectal Cancer
Second Primary Cancer

Interventions

no intervention

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

May 2024

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

May 11, 2024Estimated

Primary Completion Date

May 20, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

May 11, 2024

First Submission Date that Met QC Criteria

May 16, 2024

First Posted Date

May 21, 2024Actual

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

May 16, 2024

Last Update Posted Date

May 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 objective of this study was to analyze the pathological factors influencing the occurrence and prognosis of SPC in CRC patients of varying ages and compare the differences in the patterns of SPC occurrence and prognosis among patients of different age groups.

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

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
<50 years			Other: no intervention
50-69 years			Other: no intervention
≥70 years			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	50-69 years <50 years ≥70 years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first. Up to 100 months	The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first. Up to 100 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing radical surgery for colorectal cancer at Fudan University Shanghai Cancer Center between January 2008 and December 2018.
Stage Ⅰ-Ⅳ colorectal cancer confirmed by clear pathological information

Exclusion Criteria:

Previous history of other cancers before surgery
Patients under 18 years old or over 80 years old

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients retrieved from the database of Fudan University Shanghai Cancer Center. These patients were diagnosed with CRC primary tumors between January 2008 and December 2018.

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

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D016609	Neoplasms, Second Primary

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided