CRC (Colorectal Cancer)
Conditions
Brief summary
Monocentric retrospective and prospective observational study of patients with colorectal cancer
Detailed description
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.
Interventions
None listed
Sponsors
IRCCS San Raffaele
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant is willing and able to give informed and written consent for the participation in the study 2. Patients affected by colorectal neoplasm (regardless of disease stage) 3. Aged \> 18 years 4. Patients in clinical conditions permissive to adhere to the diagnostic-therapeutic program proposed in according to the stage of the disease
Exclusion criteria
1. Pediatric population 2. Pre-existing conditions or concurrent diagnoses that would preclude the participant's full adherence with or completion of the study 3. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of diagnosis until the date of death from any cause or last follow up, assessed up to 5 years | Overall survival, defined as the time from diagnosis to death from any cause. |
| Progression-Free Survival (PFS) | 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. | 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 |
| Disease-free survival (DFS) | 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 | Time from complete response or radical surgery to disease recurrence or death from any cause |
| R0 - Resection Rate | At the time of surgery, based on postoperative pathological assessment | Percentage of patients undergoing surgical resection with no residual tumor (R0) |
| Incidence of Treatment-Related Adverse Events | From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hospitalization | From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years | Proportion of patients requiring hospitalization during the study period. |
| Mean Change from Baseline in Laboratory Parameters | 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 | Variation from baseline in routine laboratory values (e.g., hemoglobin, liver function tests), measured as continuous variables. |
| Patient-Reported Outcomes | 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. | Change from baseline in descriptive patient-reported outcomes assessing disease-related symptoms and quality of life. |
Contacts
CONTACTValentina Burgio, Medical Oncologist
Outcome results
None listed