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

Colorectal Cancer Clinical Trial

— EOrOS  

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 (

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326879
• Other study ID #: 3527
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: October 30, 2027

Study information

• Verified date: March 2024
• Source: Istituto Clinico Humanitas
• Contact: Annalisa Maroli, PhD
• Phone: 02 8224 7776
• Email: colorapp[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: October 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• No intervention
Questionnaires compilation and sample collection

Locations

Country	Name	City	State
Italy	IRCCS Humanitas Research Hospital	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate ratio of colorectal cancer recurrence	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	24 months after surgery
Secondary	Correlation between lifestyle and incidence rate of colorectal cancer recurrence	Compare the association between physical activity, dietary, and lifestyle behaviors and 24-month colorectal cancer recurrence in the study cohorts.	24 months after surgery
Secondary	Correlation between genetic profile and incidence rate of colorectal cancer recurrence	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	24 months after surgery
Secondary	Correlation between molecular profile and incidence rate of colorectal cancer recurrence	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	24 months after surgery
Secondary	Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence	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.	24 months after surgery