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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Onset Colorectal Cancer (EOCRC) | Patients aged less or equal to 49 years old at the time of colorectal cancer diagnosis |
| |
| Late Onset Colorectal Cancer (LOCRC) | Patients aged more or equal to 50 years old at the time of colorectal cancer diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Questionnaires compilation and sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate ratio of colorectal cancer recurrence | 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 | 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between lifestyle and incidence rate of colorectal cancer recurrence | Compare the association between physical activity, dietary, and lifestyle behaviors and 24-month colorectal cancer recurrence in the study cohorts. | 24 months after surgery |
| Correlation between genetic profile and incidence rate of colorectal cancer recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include adult patients with a proven diagnosis of stage I-III colorectal adenocarcinoma, scheduled for elective curative cancer resection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | 02 8224 7776 | 0039 | colorapp@humanitas.it |
| Stefano De Zanet, MS | Contact | 02 8224 4623 | 0039 | colorapp@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, MD, PhD | IRCCS Huamanitas Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | MI | 20089 | Italy |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Serum samples collected before the surgical intervention, and six, twelve, and twenty-four months after surgery; fresh tumor sample collected at surgery; Formalin-Fixed Paraffin-Embedded (FFPE) tumor collected at 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 |
| 24 months after surgery |
| Correlation between molecular profile and incidence rate of colorectal cancer recurrence | 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 | 24 months after surgery |
| Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence | 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. | 24 months after surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |