Clinical trial NCT06326879: A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients
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 (
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: Early Onset Colorectal Cancer
Cancer survival
Genetic and molecular characterization
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adult patients with a proven diagnosis of stage I-III colorectal adenocarcinoma, scheduled for elective curative cancer resection.

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.

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).

Primary outcomes:
measure: Incidence rate ratio of colorectal cancer recurrence
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Correlation between lifestyle and incidence rate of colorectal cancer recurrence
timeFrame: 24 months after surgery
measure: Correlation between genetic profile and incidence rate of colorectal cancer recurrence
timeFrame: 24 months after surgery
measure: Correlation between molecular profile and incidence rate of colorectal cancer recurrence
timeFrame: 24 months after surgery
measure: Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence
timeFrame: 24 months after surgery
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: MI
Study officials:
affiliation: IRCCS Huamanitas Research Hospital
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: