Colorectal CancerEOrOSNCT06326879
A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients
An observational study of Colorectal Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 340 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2023to 30 Oct 2027
- 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: The study will include adult patients with a proven diagnosis of stage I-III colorectal adenocarcinoma, scheduled for elective curative cancer resection.
Who may be able to join
- Patients aged more than 18 years old at the time of inclusion.
- Patients with a proven diagnosis of colorectal adenocarcinoma, as reported by the staging histological biopsies.
- Patients with a preoperative staging I-III.
- Patients scheduled for elective curative colorectal resection.
- Patients with rectal cancer who underwent neoadjuvant therapy can be included in the study.
- Patients able and willing to comply with the protocol requirements (samples' collection and questionnaires' compilation).
Who cannot join
- Patients with metastatic disease at diagnosis.
- Patients requiring an emergent procedure.
- Patients undergoing palliative surgery (for example, fecal diversion).
- Patients with a surgical indication for benign lesions (for example, adenoma or dysplasia).
- Patients with an intraoperative finding of a lesion other than adenocarcinoma will be withdrawn from the study.
- Patients with an intraoperative finding of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
- Patients with a concomitant diagnosis of Inflammatory Bowel Disease.
- Patients with a known genetic syndrome (for example, Lynch syndrome or Familial Adenomatous Polyposis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089
Annalisa Maroli, PhD, 02 8224 7776 ext. 0039, colorapp@humanitas.it
Stefano De Zanet, MS, 02 8224 4623 ext. 0039, colorapp@humanitas.it
About this study
Official title: Early-Onset Colorectal Cancer Versus Late-Onset Colorectal Cancer: a Prospective Observational Cohort Study to Explore the Clinical, Sociodemographic, Genetic, and Molecular Characteristics Associated With Adverse Oncological Outcomes (
This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients
Read the detailed description
Early Onset Colorectal Cancer (EOCRC), defined as a Colorectal Cancer (CRC) arising before the age of 50, is increasing and displays more aggressive features compared with Late Onset Colorectal Cancer (LOCRC, with a diagnosis after the age of 50). EOCRC patients have indeed a higher incidence rate of CRC recurrence after surgery compared with LOCRC, even at early CRC stages (stage I or II). The reasons underlying the more aggressive patterns are almost unknown but may span and can be represented by a combination of socioeconomic factors (including low economic income and access to screening programs, diagnosis, or therapy), behavioral and lifestyle factors (including diet, sedentary behaviors, or increased stress and anxiety), and molecular or genetic factors.
The aim of this study is to prospectively validate our previous retrospective findings, demonstrating a higher incidence rate of CRC recurrence in early stage EOCRC, and explore the possible association between lifestyle, dietary, socioeconomics, molecular and genetic factors and postoperative CRC survival.
- Conditions
- Colorectal Cancer
- Being tested
- No intervention
- Keywords
- Early Onset Colorectal Cancer, Cancer survival, Genetic and molecular characterization
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Questionnaires compilation and sample collection
| Study group | Role | What they receive |
|---|---|---|
| Early Onset Colorectal Cancer (EOCRC) | Patients aged less or equal to 49 years old at the time of colorectal cancer diagnosis Receives: Other: No intervention | |
| Late Onset Colorectal Cancer (LOCRC) | Patients aged more or equal to 50 years old at the time of colorectal cancer diagnosis Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate ratio of colorectal cancer recurrence
Incidence rate ratio of 24-month colorectal cancer recurrence- defined as any radiological or endoscopic evidence of local recurrence or distal metastasis after the index surgery in stage I-III patients- between the study cohorts
Measured: 24 months after surgery
Secondary outcomes (4)
Correlation between lifestyle and incidence rate of colorectal cancer recurrence
Compare the association between physical activity, dietary, and lifestyle behaviors and 24-month colorectal cancer recurrence in the study cohorts.
Measured: 24 months after surgery
Correlation between genetic profile and incidence rate of colorectal cancer recurrence
Compare the association between the genetic profile of the surgical specimens, as identified by whole exome sequencing of the fresh and paraffin-embedded tumor specimen, and the 24-month CRC recurrence in the study cohorts
Measured: 24 months after surgery
Correlation between molecular profile and incidence rate of colorectal cancer recurrence
Compare the association between the molecular profile of the serum samples and surgical specimens, as identified by RNA sequencing and spatial transcriptomic analyses at different time points during the follow-up, and 24-month CRC recurrence between the study cohorts
Measured: 24 months after surgery
Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence
Compare the association between socioeconomic characteristics, including access to health resources and inclusion in screening programs or experimental therapies, and 24-month CRC recurrence in the study cohorts.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start30 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD, PhD, Principal investigator, IRCCS Huamanitas Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326879
- Sponsor's protocol ID
- 3527
- Acronym
- EOrOS
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-Onset Colorectal Cancer Versus Late-Onset Colorectal Cancer: a Prospective Observational Cohort Study to Explore the Clinical, Sociodemographic, Genetic, and Molecular Characteristics Associated With Adverse Oncological Outcomes (
- ClinicalTrials.gov ID
- NCT06326879
- Acronym / sponsor ID
- EOrOS / 3527
- Conditions
- Colorectal Cancer
- Keywords
- Early Onset Colorectal Cancer, Cancer survival, Genetic and molecular characterization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 22 Mar 2024 (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.
This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients
Detailed description
Early Onset Colorectal Cancer (EOCRC), defined as a Colorectal Cancer (CRC) arising before the age of 50, is increasing and displays more aggressive features compared with Late Onset Colorectal Cancer (LOCRC, with a diagnosis after the age of 50). EOCRC patients have indeed a higher incidence rate of CRC recurrence after surgery compared with LOCRC, even at early CRC stages (stage I or II). The reasons underlying the more aggressive patterns are almost unknown but may span and can be represented by a combination of socioeconomic factors (including low economic income and access to screening programs, diagnosis, or therapy), behavioral and lifestyle factors (including diet, sedentary behaviors, or increased stress and anxiety), and molecular or genetic factors.
The aim of this study is to prospectively validate our previous retrospective findings, demonstrating a higher incidence rate of CRC recurrence in early stage EOCRC, and explore the possible association between lifestyle, dietary, socioeconomics, molecular and genetic factors and postoperative CRC survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Onset Colorectal Cancer (EOCRC) | – | Other: No interventionPatients aged less or equal to 49 years old at the time of colorectal cancer diagnosis |
| Late Onset Colorectal Cancer (LOCRC) | – | Other: No interventionPatients aged more or equal to 50 years old at the time of colorectal cancer diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients with a proven diagnosis of stage I-III colorectal adenocarcinoma, scheduled for elective curative cancer resection.
Key inclusion criteria (6 listed)
- Patients aged more than 18 years old at the time of inclusion.
- Patients with a proven diagnosis of colorectal adenocarcinoma, as reported by the staging histological biopsies.
- Patients with a preoperative staging I-III.
- Patients scheduled for elective curative colorectal resection.
- Patients with rectal cancer who underwent neoadjuvant therapy can be included in the study.
Key exclusion criteria (8 listed)
- Patients with metastatic disease at diagnosis.
- Patients requiring an emergent procedure.
- Patients undergoing palliative surgery (for example, fecal diversion).
- Patients with a surgical indication for benign lesions (for example, adenoma or dysplasia).
- Patients with an intraoperative finding of a lesion other than adenocarcinoma will be withdrawn from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionQuestionnaires compilation and sample collection | Other | Early Onset Colorectal Cancer (EOCRC), Late Onset Colorectal Cancer (LOCRC) |
Primary outcome
Incidence rate ratio of colorectal cancer recurrence
Time frame: 24 months after surgery
Incidence rate ratio of 24-month colorectal cancer recurrence- defined as any radiological or endoscopic evidence of local recurrence or distal metastasis after the index surgery in stage I-III patients- between the study cohorts
4 secondary outcomes
Correlation between lifestyle and incidence rate of colorectal cancer recurrence
Time frame: 24 months after surgery
Correlation between genetic profile and incidence rate of colorectal cancer recurrence
Time frame: 24 months after surgery
Correlation between molecular profile and incidence rate of colorectal cancer recurrence
Time frame: 24 months after surgery
Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence
Time frame: 24 months after surgery
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 25 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Antonino Spinelli, MD, PhD principal investigator
IRCCS Huamanitas Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Annalisa Maroli, PhD (02 8224 7776 ext. 0039, colorapp@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate ratio of colorectal cancer recurrence (time frame: 24 months after surgery). 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 25 Mar 2024.