A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: No intervention

• Registration Number: NCT06326879
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2023-11-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-22
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25
• Primary Completion: 2026-12-31
• Study Completion: 2027-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late Onset Colorectal Cancer (LOCRC)	No intervention	Patients aged more or equal to 50 years old at the time of colorectal cancer diagnosis
Early Onset Colorectal Cancer (EOCRC)	No intervention	Patients aged less or equal to 49 years old at the time of colorectal cancer diagnosis

Primary Outcome Measures

Name	Time	Method
Incidence rate ratio of colorectal cancer recurrence	24 months after surgery	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

Secondary Outcome Measures

Name	Time	Method
Correlation between genetic profile and incidence rate of colorectal cancer recurrence	24 months after surgery	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
Correlation between molecular profile and incidence rate of colorectal cancer recurrence	24 months after surgery	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
Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence	24 months after surgery	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.
Correlation between lifestyle and incidence rate of colorectal cancer recurrence	24 months after surgery	Compare the association between physical activity, dietary, and lifestyle behaviors and 24-month colorectal cancer recurrence in the study cohorts.

Trial Locations

Locations (1)

IRCCS Humanitas Research Hospital; 🇮🇹 Rozzano, MI, Italy