CRC (Colorectal Cancer)CRC-RNCT07663162
Monocentric Retrospective and Prospective Observational Study of Patients With Colorectal Cancer
An observational study of CRC (Colorectal Cancer), run by IRCCS San Raffaele.
Trial summary
Monocentric retrospective and prospective observational study of patients with colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRC (Colorectal Cancer)
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged > 18 years, affected by colorectal neoplasm at any stage accessing to IRCCS Ospedale San Raffaele
Who may be able to join
- 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
Who cannot join
- Pediatric population
- Pre-existing conditions or concurrent diagnoses that would preclude the participant's full adherence with or completion of the study
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Monocentric retrospective and prospective observational study of patients with colorectal cancer
Read the 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.
- Conditions
- CRC (Colorectal Cancer)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival, defined as the time from diagnosis to death from any cause.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Proportion of patients requiring hospitalization during the study period.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2036 (estimated)
- Study completionJun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC (Colorectal Cancer)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Burgio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663162
- Sponsor's protocol ID
- CRC-R
- Acronym
- CRC-R
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Individual data sharing
- No: The study is monocentric
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Retrospective and Prospective Observational Study of Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07663162
- Acronym / sponsor ID
- CRC-R / CRC-R
- Conditions
- CRC (Colorectal Cancer)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2036 (estimated)
- Study completion
- Jun 2036 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged > 18 years, affected by colorectal neoplasm at any stage accessing to IRCCS Ospedale San Raffaele
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pediatric population
- Pre-existing conditions or concurrent diagnoses that would preclude the participant's full adherence with or completion of the study
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Overall survival, defined as the time from diagnosis to death from any cause.
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.
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)
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
R0 - Resection Rate
Time frame: 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
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. The study is monocentric
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of CRC (Colorectal Cancer), run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Burgio, Medical Oncologist (+39 022643 7627, callcenter.colonretto@hsronline.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.