NCT Number: NCT07663162
Monocentric retrospective and prospective observational study of patients with colorectal cancer
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
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.
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
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
Time from complete response or radical surgery to disease recurrence or death from any cause
Time frame: At the time of surgery, based on postoperative pathological assessment
Percentage of patients undergoing surgical resection with no residual tumor (R0)
Time frame: 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.
Time frame: 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.
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
Variation from baseline in routine laboratory values (e.g., hemoglobin, liver function tests), measured as continuous variables.
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.
Change from baseline in descriptive patient-reported outcomes assessing disease-related symptoms and quality of life.
Time frame: 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
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.
Time frame: 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
Prevalence and type of somatic genetic alterations in tumor tissue assessed with Next-Generation Sequencing (NGS).
Time frame: 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 will be assessed using high-throughput approaches, including multiplexed immunohistochemistry (IHC), to explore novel prognostic and/or predictive biomarkers.
Contact information is provided by the study sponsor or research team.
IRCCS San Raffaele
Other
Acronym: CRC-R
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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