Monocentric Retrospective and Prospective Observational Study of Patients With Colorectal Cancer

ConditionCRC (Colorectal Cancer)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIRCCS San Raffaele

About this trial

Monocentric retrospective and prospective observational study of patients with colorectal cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pediatric population

Pre-existing conditions or concurrent diagnoses that would preclude the participant's full adherence with or completion of the study

Pregnancy

Trial population

Patients aged \> 18 years, affected by colorectal neoplasm at any stage accessing to IRCCS Ospedale San Raffaele

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants

are grouped into 1 trial group

Group A: Patients affected by colorectal neoplasm (regardless of disease stage)

Trial outcomes

Primary outcomes

Overall Survival (OS)

Overall survival, defined as the time from diagnosis to death from any cause.

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)

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 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

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

Percentage of patients undergoing surgical resection with no residual tumor (R0)

Time frame

At the time of surgery, based on postoperative pathological assessment

Secondary outcomes

Incidence of Hospitalization

Proportion of patients requiring hospitalization during the study period.

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

Variation from baseline in routine laboratory values (e.g., hemoglobin, liver function tests), measured as continuous variables.

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

Change from baseline in descriptive patient-reported outcomes assessing disease-related symptoms and quality of life.

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.

Other outcomes

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.

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

Frequency of Tumor Genetic Alterations

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

Histopathological tumor features will be assessed using high-throughput approaches, including multiplexed immunohistochemistry (IHC), to explore novel prognostic and/or predictive biomarkers.

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: