## Protocol Section
### Identification Module
**NCT ID:** NCT06326879

**Acronym:** EOrOS

**Brief Title:** A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients

**Official Title:** Early-Onset Colorectal Cancer Versus Late-Onset Colorectal Cancer: a Prospective Observational Cohort Study to Explore the Clinical, Sociodemographic, Genetic, and Molecular Characteristics Associated With Adverse Oncological Outcomes (

#### Organization Study ID Info
**ID:** 3527
#### Organization
**Class:** OTHER
**Full Name:** Istituto Clinico Humanitas
### Status Module
#### Completion Date
**Date:** 2027-10-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-25

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-30

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-03-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-18
**Study First Submit QC Date:** 2024-03-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istituto Clinico Humanitas

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients

**Detailed Description:** Early Onset Colorectal Cancer (EOCRC), defined as a Colorectal Cancer (CRC) arising before the age of 50, is increasing and displays more aggressive features compared with Late Onset Colorectal Cancer (LOCRC, with a diagnosis after the age of 50). EOCRC patients have indeed a higher incidence rate of CRC recurrence after surgery compared with LOCRC, even at early CRC stages (stage I or II). The reasons underlying the more aggressive patterns are almost unknown but may span and can be represented by a combination of socioeconomic factors (including low economic income and access to screening programs, diagnosis, or therapy), behavioral and lifestyle factors (including diet, sedentary behaviors, or increased stress and anxiety), and molecular or genetic factors.

The aim of this study is to prospectively validate our previous retrospective findings, demonstrating a higher incidence rate of CRC recurrence in early stage EOCRC, and explore the possible association between lifestyle, dietary, socioeconomics, molecular and genetic factors and postoperative CRC survival.

### Conditions Module

**Conditions:**

- Colorectal Cancer

**Keywords:**

- Early Onset Colorectal Cancer

- Cancer survival

- Genetic and molecular characterization

### Design Module

#### Bio Spec

**Description:** Serum samples collected before the surgical intervention, and six, twelve, and twenty-four months after surgery; fresh tumor sample collected at surgery; Formalin-Fixed Paraffin-Embedded (FFPE) tumor collected at surgery

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 340

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients aged less or equal to 49 years old at the time of colorectal cancer diagnosis

**Intervention Names:**

- Other: No intervention

**Label:** Early Onset Colorectal Cancer (EOCRC)

#### Arm Group 2

**Description:** Patients aged more or equal to 50 years old at the time of colorectal cancer diagnosis

**Intervention Names:**

- Other: No intervention

**Label:** Late Onset Colorectal Cancer (LOCRC)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Early Onset Colorectal Cancer (EOCRC)

- Late Onset Colorectal Cancer (LOCRC)

**Description:** Questionnaires compilation and sample collection

**Name:** No intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Incidence rate ratio of 24-month colorectal cancer recurrence- defined as any radiological or endoscopic evidence of local recurrence or distal metastasis after the index surgery in stage I-III patients- between the study cohorts

**Measure:** Incidence rate ratio of colorectal cancer recurrence

**Time Frame:** 24 months after surgery

#### Secondary Outcomes

**Description:** Compare the association between physical activity, dietary, and lifestyle behaviors and 24-month colorectal cancer recurrence in the study cohorts.

**Measure:** Correlation between lifestyle and incidence rate of colorectal cancer recurrence

**Time Frame:** 24 months after surgery

**Description:** Compare the association between the genetic profile of the surgical specimens, as identified by whole exome sequencing of the fresh and paraffin-embedded tumor specimen, and the 24-month CRC recurrence in the study cohorts

**Measure:** Correlation between genetic profile and incidence rate of colorectal cancer recurrence

**Time Frame:** 24 months after surgery

**Description:** Compare the association between the molecular profile of the serum samples and surgical specimens, as identified by RNA sequencing and spatial transcriptomic analyses at different time points during the follow-up, and 24-month CRC recurrence between the study cohorts

**Measure:** Correlation between molecular profile and incidence rate of colorectal cancer recurrence

**Time Frame:** 24 months after surgery

**Description:** Compare the association between socioeconomic characteristics, including access to health resources and inclusion in screening programs or experimental therapies, and 24-month CRC recurrence in the study cohorts.

**Measure:** Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence

**Time Frame:** 24 months after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients aged more than 18 years old at the time of inclusion.
* Patients with a proven diagnosis of colorectal adenocarcinoma, as reported by the staging histological biopsies.
* Patients with a preoperative staging I-III.
* Patients scheduled for elective curative colorectal resection.
* Patients with rectal cancer who underwent neoadjuvant therapy can be included in the study.
* Patients able and willing to comply with the protocol requirements (samples' collection and questionnaires' compilation).

Exclusion Criteria:

* Patients with metastatic disease at diagnosis.
* Patients requiring an emergent procedure.
* Patients undergoing palliative surgery (for example, fecal diversion).
* Patients with a surgical indication for benign lesions (for example, adenoma or dysplasia).
* Patients with an intraoperative finding of a lesion other than adenocarcinoma will be withdrawn from the study.
* Patients with an intraoperative finding of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
* Patients with a concomitant diagnosis of Inflammatory Bowel Disease.
* Patients with a known genetic syndrome (for example, Lynch syndrome or Familial Adenomatous Polyposis).

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study will include adult patients with a proven diagnosis of stage I-III colorectal adenocarcinoma, scheduled for elective curative cancer resection.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** colorapp@humanitas.it

**Name:** Annalisa Maroli, PhD

**Phone:** 02 8224 7776

**Phone Ext:** 0039

**Role:** CONTACT

**Contact 2:**

**Email:** colorapp@humanitas.it

**Name:** Stefano De Zanet, MS

**Phone:** 02 8224 4623

**Phone Ext:** 0039

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rozzano

**Contacts:**

***Contact 1:***

- **Email:** colorapp@humanitas.it

- **Name:** Annalisa Maroli, PhD

- **Phone:** 02 8224 7776

- **Phone Ext:** 0039

- **Role:** CONTACT

***Contact 2:***

- **Email:** colorapp@humanitas.it

- **Name:** Stefano De Zanet, MS

- **Phone:** 02 8224 4623

- **Phone Ext:** 0039

- **Role:** CONTACT

**Country:** Italy

**Facility:** IRCCS Humanitas Research Hospital

**State:** MI

**Status:** RECRUITING

**Zip:** 20089

#### Overall Officials

**Official 1:**

**Affiliation:** IRCCS Huamanitas Research Hospital

**Name:** Antonino Spinelli, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### 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: D000009369

- Term: Neoplasms

- 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: 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: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal 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

### Misc Info Module

- Version Holder: 2024-05-24
