Monocentric Retrospective and Prospective Observational Study of Patients With Colorectal Cancer

NCT07663162 | Not Yet Recruiting

• 1 other identifier: CRC-R
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Monocentric retrospective and prospective observational study of patients with colorectal cancer

Conditions

CRC (Colorectal Cancer)

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (3)

• Incidence of Hospitalization

  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

  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

  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 (3)

• Mean Change from Baseline in Immunological Biomarkers

  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

  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

  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

Study Arms (1)

Patients affected by colorectal neoplasm (regardless of disease stage)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Valentina Burgio, Medical Oncologist

CONTACT

+39 022643 7627; callcenter.colonretto@hsronline.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: June 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): June 1, 2036
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share