Actively Recruiting
Early-Onset Colorectal Cancer Versus Late-Onset Colorectal Cancer: a Prospective Observational Cohort Study to Explore Clinical, Sociodemographic, Genetic, and Molecular Characteristics Associated With Adverse Outcomes
Led by Istituto Clinico Humanitas · Updated on 2024-03-25
340
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the differences between Early Onset Colorectal Cancer (EOCRC), which occurs before age 50, and Late Onset Colorectal Cancer (LOCRC), diagnosed after age 50. EOCRC tends to be more aggressive and has a higher chance of cancer recurrence after surgery, even in early stages. The study aims to validate previous findings and explore how clinical, socioeconomic, behavioral, genetic, and molecular factors relate to cancer outcomes in these patients. Participants will be divided into two groups based on their age at diagnosis: those 49 years old or younger (EOCRC) and those 50 years or older (LOCRC). There is no intervention in this observational study; instead, participants will complete questionnaires and provide samples to gather information on lifestyle, diet, genetics, and socioeconomic status. The study will follow patients for 24 months after surgery to monitor cancer recurrence and other outcomes. During the study, participants will complete questionnaires and provide biological samples. Researchers will collect data on cancer recurrence rates, lifestyle habits, genetic and molecular profiles, and socioeconomic factors. The primary measure is the rate of colorectal cancer recurrence 24 months after surgery. Secondary analyses will look at how lifestyle, genetics, molecular characteristics, and socioeconomic status relate to recurrence. The study is designed to better understand factors influencing colorectal cancer outcomes over a two-year period.
CONDITIONS
Brief Title
A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged more than 18 years old at the time of inclusion.
- Patients with a proven diagnosis of colorectal adenocarcinoma.
- 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.
- Patients able and willing to comply with protocol requirements including sample collection and questionnaire completion.
You will not qualify if you...
- Patients with metastatic disease at diagnosis.
- Patients requiring an emergent procedure.
- Patients undergoing palliative surgery.
- Patients with surgical indication for benign lesions.
- Patients with intraoperative finding of a lesion other than adenocarcinoma.
- Patients with intraoperative finding of distal metastasis or peritoneal carcinomatosis.
- Patients with a diagnosis of Inflammatory Bowel Disease.
- Patients with a known genetic syndrome such as Lynch syndrome or Familial Adenomatous Polyposis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months after surgery
Participants who have undergone elective curative colorectal resection are observed to explore associations between lifestyle, genetic, molecular, and socioeconomic factors and colorectal cancer recurrence.
Periodic follow-up visits for up to 24 months
Trial Site Locations
Total: 1 location
1
IRCCS Humanitas Research Hospital
Rozzano, MI, Italy, 20089
Actively Recruiting
Research Team
A
Annalisa Maroli, PhD
S
Stefano De Zanet, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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