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Recruiting NCT06326879

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

— Observational Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 (

Overview

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.

Interventions

  • Other No intervention
    Questionnaires compilation and sample collection

Primary outcome measures

  • Incidence rate ratio of colorectal cancer recurrence [Time frame: 24 months after surgery]
Secondary outcome measures (4)
  • Correlation between lifestyle and incidence rate of colorectal cancer recurrence [Time frame: 24 months after surgery]
  • Correlation between genetic profile and incidence rate of colorectal cancer recurrence [Time frame: 24 months after surgery]
  • Correlation between molecular profile and incidence rate of colorectal cancer recurrence [Time frame: 24 months after surgery]
  • Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence [Time frame: 24 months after surgery]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Humanitas Research Hospital — Rozzano

Identifiers

NCT: NCT06326879 · 3527

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗