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

NCT ID: NCT06326879

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 340 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2027-10-30

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

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early Onset Colorectal Cancer (EOCRC)

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

No intervention

Intervention Type: OTHER

Questionnaires compilation and sample collection

Late Onset Colorectal Cancer (LOCRC)

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

No intervention

Intervention Type: OTHER

Questionnaires compilation and sample collection

Interventions

No intervention

Questionnaires compilation and sample collection

Intervention Type: OTHER

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 Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonino Spinelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Huamanitas Research Hospital

Locations

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Annalisa Maroli, PhD

Role: CONTACT

colorapp@humanitas.it

02 8224 7776 ext. 0039

Stefano De Zanet, MS

Role: CONTACT

colorapp@humanitas.it

02 8224 4623 ext. 0039

Facility Contacts

Annalisa Maroli, PhD

Role: primary

colorapp@humanitas.it

02 8224 7776 ext. 0039

Stefano De Zanet, MS

Role: backup

colorapp@humanitas.it

02 8224 4623 ext. 0039

Other Identifiers

3527

Identifier Type: -

Identifier Source: org_study_id