Comparing Early and Late Onset Colorectal Cancer Patients
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 (
Istituto Clinico Humanitas · NCT06326879
This study looks at the differences between younger and older patients with colorectal cancer to see why younger patients might have a tougher time after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas (other) |
| Locations | 1 site (Rozzano, MI) |
| Trial ID | NCT06326879 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the differences in clinical, socioeconomic, behavioral, genetic, and molecular factors between patients diagnosed with Early Onset Colorectal Cancer (EOCRC) before age 50 and those diagnosed with Late Onset Colorectal Cancer (LOCRC) after age 50. The study aims to validate previous findings regarding the higher recurrence rates of colorectal cancer in EOCRC patients and explore associations with various factors affecting postoperative survival. By collecting data through questionnaires and biological samples, the study seeks to provide insights into the aggressive nature of EOCRC and its underlying causes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of colorectal adenocarcinoma at stages I-III who are scheduled for elective curative surgery.
Not a fit: Patients with metastatic colorectal cancer or those requiring emergency or palliative procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management strategies for patients with Early Onset Colorectal Cancer.
How similar studies have performed: While studies on colorectal cancer exist, this specific comparative approach focusing on early versus late onset is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rozzano, MI
- IRCCS Humanitas Research Hospital — Rozzano, MI, Italy (RECRUITING)
Study contacts
- Principal investigator: Antonino Spinelli, MD, PhD — IRCCS Huamanitas Research Hospital
- Study coordinator: Annalisa Maroli, PhD
- Email: colorapp@humanitas.it
- Phone: 02 8224 7776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, Early Onset Colorectal Cancer, Cancer survival, Genetic and molecular characterization