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Monocentric retrospective and prospective observational study of patients with colorectal cancer
Monocentric retrospective and prospective observational study of patients with colorectal cancer The study aims to collect all data (pathological, radiological, surgical, molecular, therapeutics, stage of disease, patients' age, laboratory exams) of patients with colorectal neoplasm, at any stage and accessing to IRCCS Ospedale San Raffaele, with the purpose to analyse patients' outcomes and relating them with the above mentioned features. Moreover, biological samples will be collected at different clinically relevant endpoints to seek potential biomarker useful to a better management of CRC.
Additional biological samples (blood volume collection, approximately 30 mL) will be collected before, during and after treatment at specific timepoints, such as baseline, at disease progression and pre- and post-surgery when applicable.
For the retrospective cohort patients with colorectal cancer accessing to IRCCS Ospedale San Raffaele from 2020 to the data of protocol approval will be included (approx. 500 patients). For the prospective cohort approximately 1500 patients will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients affected by colorectal neoplasm (regardless of disease stage) | Inclusion Criteria
Exclusion Criteria
|
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival, defined as the time from diagnosis to death from any cause. | From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years |
| Progression-Free Survival (PFS) | Progression-free survival (PFS), defined as the time from the start of each treatment line to the first documented disease progression or death from any cause, whichever occurs first, according to RECIST version 1.1. PFS will be assessed separately for each treatment line received by the patient | From date of start of each treatment line until the date of first documented progression or date of death from any cause, assessed up to 12 months. Tumor assessments will be performed in accordance with clinical practice. |
| Disease-free survival (DFS) | Time from complete response or radical surgery to disease recurrence or death from any cause | From date of surgery or complete response until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 5 years. Tumor assessments will be performed in accordance with clinical practice |
| R0 - Resection Rate | Percentage of patients undergoing surgical resection with no residual tumor (R0) | At the time of surgery, based on postoperative pathological assessment |
| Incidence of Treatment-Related Adverse Events | Frequency and severity of adverse events related to treatment, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v.6. | From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hospitalization | Proportion of patients requiring hospitalization during the study period. | From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years |
| Mean Change from Baseline in Laboratory Parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Immunological Biomarkers | Changes in immunological biomarkers will be assessed through the evaluation of soluble factors (such as cytokines) and immunophenotype of circulating and tumor-resident immune cells. | At all clinically relevant timepoints (such as baseline, at first disease revaluation, at disease progression, pre- and post-surgery) until the date of death from any cause or last follow up, assessed up to 5 years |
Inclusion Criteria:
Exclusion Criteria:
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Patients aged > 18 years, affected by colorectal neoplasm at any stage accessing to IRCCS Ospedale San Raffaele
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Burgio, Medical Oncologist | Contact | +39 022643 7627 | callcenter.colonretto@hsronline.it |
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The study is monocentric
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2026 | May 6, 2026 | Prot_000.pdf |
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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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Variation from baseline in routine laboratory values (e.g., hemoglobin, liver function tests), measured as continuous variables. |
| From treatment initiation, during routine laboratory examination (every month as per clinical practice) and at disease progression until the date of death from any cause or last follow up, assessed up to 5 years |
| Patient-Reported Outcomes | Change from baseline in descriptive patient-reported outcomes assessing disease-related symptoms and quality of life. | At baseline and during scheduled visits as per clinical practice until the date of death from any cause or last follow up, assessed up to 5 years. |
| Frequency of Tumor Genetic Alterations | Prevalence and type of somatic genetic alterations in tumor tissue assessed with Next-Generation Sequencing (NGS). | At all clinically relevant timepoints (such as at baseline, surgery and disease progression) until the date of death from any cause or last follow up, assessed up to 5 years |
| Histopathological Tumor Features | Histopathological tumor features will be assessed using high-throughput approaches, including multiplexed immunohistochemistry (IHC), to explore novel prognostic and/or predictive biomarkers. | At all clinically relevant timepoints (such as at baseline, surgery and disease progression) until the date of death from any cause or last follow up, assessed up to 5 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |