Exploring distinctive characteristics of gastrointestinal cancer diagnosed in patients below 50 years old compared to patients diagnosed at an older age in the Northern area of Spain
| ISRCTN | ISRCTN16690312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16690312 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PI23/01514 |
| Sponsor | Navarre Institute of Health Research |
| Funder | Instituto de Salud Carlos III |
- Submission date
- 17/04/2024
- Registration date
- 02/05/2024
- Last edited
- 16/05/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Gastrointestinal cancers (cancers that develop in the digestive tract) are one of the most common diseases worldwide. Strikingly, the incidence of early onset gastrointestinal cancer (EOGIC) has been rising during the last decades and changes in lifestyle and environment seem to play a role. EOGIC has been defined as a different entity compared to on-average gastrointestinal cancer, with distinct clinical and molecular characteristics. There is an unmet need for a tailored approach to the management of these patients. The aim of this study is to characterize EOGIC patients in northern Spain.
Who can participate?
Patients with a new diagnosis of colorectal, gastroesophageal and pancreatic adenocarcinoma: EOGIC (up to 50 years old) and non-EOGIC (60-75 years old)
What does the study involve?
The demographic and clinical data of the patients will be collected. Lifestyle-related data will be obtained in questionnaires assessing diet, physical activity and the general quality of life of the patients before diagnosis. Biological samples will be collected before any cancer treatment including feces, blood and tumor tissue.
What are the possible benefits and risks of participating?
This is an observational study with no risks. Patients will not directly benefit from their participation in the study. The findings of this study could help to raise awareness and promote preventive behaviours. Molecular studies could lead to the identification of potential novel non-invasive biomarkers and therapeutic targets that would help in the development of the tailored clinical management of these patients, focusing on screening programs for early diagnosis and precision medicine.
Where is the study run from?
Health Research Institute of Navarra (IdiSNA) (Spain)
When is the study starting and how long is it expected to run for?
April 2023 to December 2026
Who is funding the study?
Carlos III Health Institute (Spain)
Who is the main contact?
Dr Maria Alsina, teogic@navarra.es
Contact information
Public, Scientific, Principal investigator
Irunlarrea 3
Pamplona-Iruña
31008
Spain
 ORCID ID |
0000-0003-4835-7159 |
|---|---|
| Phone | +34 (0)848428135 |
| teogic@navarra.es |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational transversal and multicenter study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Transversal study of early-onset gastrointestinal cancer |
| Study acronym | TEOGIC |
| Study objectives | Patients with early onset gastrointestinal cancer (EOGIC, i.e. diagnosed in patients ≤50 years old) bear distinctive clinical, biological and lifestyle-related characteristics in comparison to patients with gastrointestinal cancer diagnosed at an on-average age (non-EOGIC). |
| Ethics approval(s) |
Approved 19/12/2023, Comité De Ética De La Investigación Con Medicamentos (Irunlarrea 3, Pamplona-Iruña, 31008, Spain; +34 (0)848422495; ceic@navarra.es), ref: PI_2023/144 |
| Health condition(s) or problem(s) studied | Gastrointestinal cancer: colorrectal adenocarcinoma, gastroesophageal adenocarcinoma, pancreatic adenocarcinoma |
| Intervention | Patients with a histologically confirmed new diagnosis of colorectal, gastroesophageal and pancreatic adenocarcinoma will be considered for two cohorts: EOGIC (≤50 years old) and non-EOGIC (60-75 years old), with a ratio of 1:2. After signing the unified informed consent, demographic and clinical data of the patients will be collected in a REDCap database. Lifestyle-related data will be obtained in questionnaires assessing diet, physical activity and the general quality of life of the patients before diagnosis. Biological samples will be obtained prior to any onco-specific treatment including feces, blood and tumor tissue (provided available material exists after all necessary determinations for cancer diagnosis and treatment) for the analysis of circulating inflammatory proteins, gut microbiota, and the proteome of the tumor microenvironment. |
| Intervention type | Other |
| Primary outcome measure(s) |
All data and samples will be collected at diagnosis, before patient has received any onco-specific treatment: |
| Key secondary outcome measure(s) |
Comparison between each tumor type, and pan-tumor between sexes using primary outcome measure data as above. |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Key inclusion criteria | 1. Newly diagnosed, histologically confirmed colorectal adenocarcinoma (CRC, group A), gastroesophageal adenocarcinoma (GEC, group B) and pancreatic adenocarcinoma (PC, group C) 2. Aged 18-50 years (both included) years old for the EOGIC group, and aged 60-75 years (both included) years old for the non-EOGIC group |
| Key exclusion criteria | 1. Eastern Cooperative Oncology Group (ECOG) performance status of ≥3 2. Presence of comorbidities which may compromise participation of the patient in the study (mainly in terms of capability to complete the questionnaires) 3. Having received oncological treatment directed at the newly diagnosed cancer (i.e., at the time of inclusion the patient has not yet started any type of treatment, including surgery) |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Spain
Study participating centres
Pamplona-Iruña
31008
Spain
Zaragoza
50009
Spain
Donostia-San Sebastián
20014
Spain
Logroño
26006
Spain
Barcelona
08035
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The data underlying this study cannot be shared publicly due to ethical restrictions. After publication of the study findings, data sharing will be considered upon request to the principal investigator/corresponding author Dr Maria Alsina (teogic@navarra.es). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/05/2024: Internal review.
17/04/2024: Study's existence confirmed by Instituto de Salud Carlos III.
