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NCT Number: NCT06326879

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention

Other

Questionnaires compilation and sample collection

Primary outcomes

  1. Incidence rate ratio of colorectal cancer recurrence

    Time frame: 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 outcomes

  1. Correlation between lifestyle and incidence rate of colorectal cancer recurrence

    Time frame: 24 months after surgery

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

  2. Correlation between genetic profile and incidence rate of colorectal cancer recurrence

    Time frame: 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

  3. Correlation between molecular profile and incidence rate of colorectal cancer recurrence

    Time frame: 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

  4. Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annalisa Maroli, PhD

CONTACT

[email protected]

02 8224 7776 ext. 0039

Stefano De Zanet, MS

CONTACT

[email protected]

02 8224 4623 ext. 0039

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study 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 (

Acronym: EOrOS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 22, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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