Colorectal Cancer in Patients Under 50 Years of AgeCCR50NCT07026955
Colorectal Cancer in Young Adults: Study of Incidence, Survival, and Prognostic Factors in Tarragona, Spain
An observational study of Colorectal Cancer in Patients Under 50 Years of Age and Colorectal Cancer, run by HJ23 at 1 site in Spain.
Trial summary
We conducted an observational, descriptive, longitudinal and retrospective study of 59 patients under 50 years of age diagnosed with CRC in the province of Tarragona, between 2019 and 2024. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Colorectal Cancer in Patients Under 50 Years of Age, Colorectal Cancer
- What is being tested?
- colorectal cancer in patients over 50 years of age
- How many people
- 59 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: all patients under 50 years of age diagnosed with colorectal cance
Who may be able to join
- patients under 50 years of age
- diagnosed: colorectal cancer
Who cannot join
- over 50 years of age,
- Primary tumors of non-colorectal origin
- individuals diagnosed with polyps with low-grade dysplasia, hyperplastic polyps
- other non-neoplastic colorectal conditions.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Tarragona Joan XXIII
Tarragona, Tarragona, 43201
About this study
We conducted an observational, descriptive, longitudinal and retrospective study of 59 patients under 50 years of age diagnosed with CRC in the province of Tarragona, between 2019 and 2024. Sociodemographic, clinical, anatomopathological and evolutionary variables provided from the data collected in the registry of the Colorectal Cancer Committee of the Joan XXIII University Hospital (HJ23) were analyzed.
Read the detailed description
Study Design
This descriptive, longitudinal, observational, retrospective study included patients under 50 diagnosed with colorectal cancer at HJ23 between 2019 and 2024. The protocol was approved by the CEIm IISPV (ref. 009/2024)
Study Population
Participants Data were obtained from patients under 50 years of age diagnosed with CRC and evaluated by the colorectal cancer multidisciplinary team (MDT) at the HJ23 during the period 2019-2024.
Inclusion criteria included all patients under 50 years of age diagnosed with CRC and evaluated by the MDT during the specified period.
Exclusion criteria comprised patients over 50 years of age, those with primary tumors of non-colorectal origin, and individuals diagnosed with polyps with low-grade dysplasia, hyperplastic polyps, or other non-neoplastic colorectal conditions.
Study Methods
Data were obtained from the registry of patients presented at the Multidisciplinary Colorectal Cancer Committee of the HJ23 between 2019 and 2024.
The hospital informatic team provided a refined list of medical record numbers for patients under 50 years of age evaluated by the committee.
The information was encoded into a password-protected Microsoft Access database hosted on the hospital intranet. Subsequently, detailed review of medical records was conducted, resulting in a pseudonymized dataset for analysis.
Study Variables Sociodemographic variables included sex (male or female), age (under 50), and referring hospital to assess the demographic distribution by origin.
Clinical characteristics included date of first symptom, reason for consultation, poor prognostic factors, and tumor staging using the TNM classification , based on clinical, imaging, and/or pathological data.
Management and follow-up variables included date of presentation to the MDT, the treatment decision taken, presence of local recurrence or metastases, date of last surgical follow-up, and, if applicable, date of death.
Diagnostic procedures included colonoscopy, date, distance from anal verge in centimeters, and histopathological findings. Imaging studies included the performance of CT scans, recording whether performed and the date of examination.
Surgical treatment variables included whether surgery was performed, date of surgery, surgical approach (open, laparoscopic, robotic).
Histopathological variables for operated patients included the pathological evaluation of the surgical specimen, TNM staging, lymphovascular invasion, distant metastases, tumor budding grade (low, intermediate, high, or not assessable), and MSH2/MSH6 mismatch repair protein expression (preserved/not preserved). Postoperative complications were classified using the Clavien-Dindo scale. Data on genetic counseling were also recorded, including conclusions on pathogenic variants, variants of uncertain significance, or benign findings.
Statistical Analysis Quantitative variables with a normal distribution were expressed as mean and standard deviation (SD); otherwise, they were presented as median and interquartile range (IQR). Categorical variables were described using mode and proportions. The Shapiro-Wilk test was used to assess the normality of continuous variables. A p-value < 0.05 was considered statistically significant. If normality was not confirmed, p-values were obtained using permutation tests.
Group comparisons were made using Fisher's exact test for categorical variables, and the Student's t-test or ANOVA for normally distributed quantitative variables. For non-normal distributions, the Wilcoxon-Mann-Whitney test was used for two groups, and the Kruskal-Wallis test for more than two groups. Fisher's and McNemar's tests were used for contingency tables, as appropriate.
All analyses were performed using STATA© (StataCorp), conducted by a statistician specialized in data processing and analysis.
- Being tested
- colorectal cancer in patients over 50 years of age
- Keywords
- Colorectal cancer, cancer screening, early onset 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.
colorectal cancer in patients over 50 years of ageOther
description
| Study group | Role | What they receive |
|---|---|---|
| colorectal cancer in patients under 50 years of age | Not described Receives: Other: colorectal cancer in patients over 50 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
INCIDENCE
describe the incidence of colorectal cancer in individuals under 50 years of age in the population of the province of Tarragona.
Measured: 5 year
Secondary outcomes (4)
mortality
describe the mortality of colorectal cancer in individuals under 50 years of age in the population of the province of Tarragona.
Measured: 5 years
survival
describe the survival of colorectal cancer in individuals under 50 years of age in the population of the province of Tarragona.
Measured: 5 years
prognostic factor
describe the prognostic factor of colorectal cancer in individuals under 50 years of age in the population of the province of Tarragona.
Measured: 5 year
cancer treatment
to describe the various medical and surgical treatments received by the patients
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Oct 2024
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer in Patients Under 50 Years of AgeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- HJ23
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joan XXIII University Hospital
- Responsible party
- Principal investigator, Jordi Elvira Lopez, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026955
- Sponsor's protocol ID
- CGD-HJ23
- Other IDs
- 009/2024
- Acronym
- CCR50
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there ara a anonymous data, so we can share
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer in Young Adults: Study of Incidence, Survival, and Prognostic Factors in Tarragona, Spain
- ClinicalTrials.gov ID
- NCT07026955
- Acronym / sponsor ID
- CCR50 / CGD-HJ23
- Keywords
- Colorectal cancer, cancer screening, early onset cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- HJ23Industry (pharma, biotech, devices)
- Collaborators
- Joan XXIII University Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 18 Jun 2025 (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.
We conducted an observational, descriptive, longitudinal and retrospective study of 59 patients under 50 years of age diagnosed with CRC in the province of Tarragona, between 2019 and 2024. Sociodemographic, clinical, anatomopathological and evolutionary variables provided from the data collected in the registry of the Colorectal Cancer Committee of the Joan XXIII University Hospital (HJ23) were analyzed.
Detailed description
Study Design
This descriptive, longitudinal, observational, retrospective study included patients under 50 diagnosed with colorectal cancer at HJ23 between 2019 and 2024. The protocol was approved by the CEIm IISPV (ref. 009/2024)
Study Population
Participants Data were obtained from patients under 50 years of age diagnosed with CRC and evaluated by the colorectal cancer multidisciplinary team (MDT) at the HJ23 during the period 2019-2024.
Inclusion criteria included all patients under 50 years of age diagnosed with CRC and evaluated by the MDT during the specified period.
Exclusion criteria comprised patients over 50 years of age, those with primary tumors of non-colorectal origin, and individuals diagnosed with polyps with low-grade dysplasia, hyperplastic polyps, or other non-neoplastic colorectal conditions.
Study Methods
Data were obtained from the registry of patients presented at the Multidisciplinary Colorectal Cancer Committee of the HJ23 between 2019 and 2024.
The hospital informatic team provided a refined list of medical record numbers for patients under 50 years of age evaluated by the committee.
The information was encoded into a password-protected Microsoft Access database hosted on the hospital intranet. Subsequently, detailed review of medical records was conducted, resulting in a pseudonymized dataset for analysis.
Study Variables Sociodemographic variables included sex (male or female), age (under 50), and referring hospital to assess the demographic distribution by origin.
Clinical characteristics included date of first symptom, reason for consultation, poor prognostic factors, and tumor staging using the TNM classification , based on clinical, imaging, and/or pathological data.
Management and follow-up variables included date of presentation to the MDT, the treatment decision taken, presence of local recurrence or metastases, date of last surgical follow-up, and, if applicable, date of death.
Diagnostic procedures included colonoscopy, date, distance from anal verge in centimeters, and histopathological findings. Imaging studies included the performance of CT scans, recording whether performed and the date of examination.
Surgical treatment variables included whether surgery was performed, date of surgery, surgical approach (open, laparoscopic, robotic).
Histopathological variables for operated patients included the pathological evaluation of the surgical specimen, TNM staging, lymphovascular invasion, distant metastases, tumor budding grade (low, intermediate, high, or not assessable), and MSH2/MSH6 mismatch repair protein expression (preserved/not preserved). Postoperative complications were classified using the Clavien-Dindo scale. Data on genetic counseling were also recorded, including conclusions on pathogenic variants, variants of uncertain significance, or benign findings.
Statistical Analysis Quantitative variables with a normal distribution were expressed as mean and standard deviation (SD); otherwise, they were presented as median and interquartile range (IQR). Categorical variables were described using mode and proportions. The Shapiro-Wilk test was used to assess the normality of continuous variables. A p-value < 0.05 was considered statistically significant. If normality was not confirmed, p-values were obtained using permutation tests.
Group comparisons were made using Fisher's exact test for categorical variables, and the Student's t-test or ANOVA for normally distributed quantitative variables. For non-normal distributions, the Wilcoxon-Mann-Whitney test was used for two groups, and the Kruskal-Wallis test for more than two groups. Fisher's and McNemar's tests were used for contingency tables, as appropriate.
All analyses were performed using STATA© (StataCorp), conducted by a statistician specialized in data processing and analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer in patients under 50 years of age | – | Other: colorectal cancer in patients over 50 years of age |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- all patients under 50 years of age diagnosed with colorectal cance
Key inclusion criteria (2 listed)
- patients under 50 years of age
- diagnosed: colorectal cancer
Key exclusion criteria (4 listed)
- over 50 years of age,
- Primary tumors of non-colorectal origin
- individuals diagnosed with polyps with low-grade dysplasia, hyperplastic polyps
- other non-neoplastic colorectal conditions.
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 |
|---|---|---|
| colorectal cancer in patients over 50 years of agedescription | Other | colorectal cancer in patients under 50 years of age |
Primary outcome
INCIDENCE
Time frame: 5 year
describe the incidence of colorectal cancer in individuals under 50 years of age in the population of the province of Tarragona.
4 secondary outcomes
mortality
Time frame: 5 years
survival
Time frame: 5 years
prognostic factor
Time frame: 5 year
cancer treatment
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. there ara a anonymous data, so we can share
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in Patients Under 50 Years of Age and Colorectal Cancer, run by HJ23 at 1 site in Spain.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jun 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INCIDENCE (time frame: 5 year). 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 18 Jun 2025.