## Protocol Section
### Identification Module
**NCT ID:** NCT06423924

**Brief Title:** Second Primary Cancer and Early-onset Colorectal Cancer

**Official Title:** Risk Factors, Cancer Types and Prognostic Significance of Second Primary Cancer Based on the Early-onset and Late-onset Colorectal Cancer

#### Organization Study ID Info
**ID:** CRCSPM
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-11

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** LI XIN-XIANG

#### Responsible Party

**Investigator Affiliation:** Fudan University

**Investigator Full Name:** LI XIN-XIANG

**Investigator Title:** professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Colorectal Cancer

- Second Primary Cancer

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 10000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: no intervention

**Label:** <50 years

#### Arm Group 2

**Intervention Names:**

- Other: no intervention

**Label:** 50-69 years

#### Arm Group 3

**Intervention Names:**

- Other: no intervention

**Label:** ≥70 years

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 50-69 years

- <50 years

- ≥70 years

**Description:** no intervention

**Name:** no intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** overall survival

**Time Frame:** 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

### 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_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.

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M18989

- Name: Neoplasms, Second Primary

- Relevance: HIGH

- As Found: Second Primary Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000009369

- Term: Neoplasms

- ID: D000016609

- Term: Neoplasms, Second Primary

### Misc Info Module

- Version Holder: 2024-05-31
