Monocentric Retrospective and Prospective Observational Study of Patients With Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: CRC (Colorectal Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Overall Survival (OS) [Time frame: 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) [Time frame: 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 frame: 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 [Time frame: At the time of surgery, based on postoperative pathological assessment]
- Incidence of Treatment-Related Adverse Events [Time frame: From treatment initiation until the date of death from any cause or last follow up, assessed up to 5 years]
Secondary outcome measures (3)
- Incidence of Hospitalization [Time frame: 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 [Time frame: 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 [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- Participant is willing and able to give informed and written consent for the participation in the study
- Patients affected by colorectal neoplasm (regardless of disease stage)
- Aged > 18 years
- Patients in clinical conditions permissive to adhere to the diagnostic-therapeutic program proposed in according to the stage of the disease
Exclusion criteria
- Pediatric population
- Pre-existing conditions or concurrent diagnoses that would preclude the participant's full adherence with or completion of the study
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07663162 · CRC-R