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 |
| Secondary identifying numbers | PI23/01514 |
- 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
| Study design | Observational transversal and multicenter study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Other, Prevention, Quality of life, Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | All data and samples will be collected at diagnosis, before patient has received any onco-specific treatment: 1. Histopathological characteristics: 1.1. Molecular characteristics to be recorded in FFPE tissue include MMR/MSI status by immunohistochemical analysis of mismatch-repair proteins (MLH1, MSH2, MSH6, and PMS2) as well as CD3 and CD8 infiltration in all tumors. 1.2. Additional molecular characteristics will also be measured according to tumor type: HER2 amplification status immunohistochemistry and fluorescence in situ hybridization-based confirmation when needed), KRAS, NRAS and BRAF mutations for CRC (qPCR with Idylla equipment); HER2 overexpression/amplification status (immunohistochemistry and fluorescence in situ hybridization-based confirmation when needed), PDL1 (CPS), CLDN 18.2 and FGFR2b expression (immunohistochemistry) for GEC; and KRAS mutations (qPCR with Idylla equipment) for PC. For all tumors, Next-Generation Sequencing (NGS) analyses targeting cancer-related genes will be performed if a suitable sample is available. 2. Type and quality of life 2.1. Physical activity: Adapted GPAQ questionnaire 2.2. Quality of life: Adapted SF-36 questionnaire 2.3. Dietary habits: FFQ questionnaire (This questionnaire was developed fully in Spanish and based on dietary habits in the country, since its development it has also been updated in agreement with food composition tables for Spain) 3. Fecal microbiome: libraries will be prepared with the xGen Amplicon Panels for 16S and IST1 kit (IDT), which allows for the PCR-based enrichment on the 16S v2 V1-V9 rRNA regions. Thereafter, sequencing will be carried out on the Illumina NovaSeq platform. 4. Tumour microenvironment (proteome): Proteomic analyses will be conducted in the Proteomics unit of Navarrabiomed (ISO9001:2015 certified). Samples will undergo "in-gel" digestion, peptide reconstitution, and purification before identification by liquid chromatography-tandem mass spectrometry (LC-MS/MS), using the Ultimate 3000 RSLCnano system coupled with an Orbitrap Exploris 480 mass spectrometer (Thermo Fisher Scientific). 5. Circulating inflammatory and tumour inflammatory profile: A panel of 96 key proteins involved in tumoral and inflammatory processes will be assessed by the proximity extension assay (PEA) technology (Olink® Target 96 Immuno-Oncology). |
| Secondary outcome measures | Comparison between each tumor type, and pan-tumor between sexes using primary outcome measure data as above. |
| Overall study start date | 25/04/2023 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Research organisation
Irunlarrea 3
31008
31008
Spain
| Phone | +34 (0)848 42 87 00 |
|---|---|
| info.idisna@navarra.es | |
| Website | https://www.idisna.es/portal/default.aspx |
"ROR" |
https://ror.org/023d5h353 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The researchers plan to disseminate their results in international and national scientific meetings such as those organized by the European Society of Medical Oncology (ESMO) and the Spanish Society of Medical Oncology, as well as cooperative groups such as the European Organisation for Research and Treatment of Cancer (EORTC) and Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). They also plan to publish their findings in a high-impact scientific peer-reviewed journal. Additionally, the researchers will organize divulgative events with patient organizations of the participating areas in order to raise awareness about the study and early onset gastrointestinal cancer. |
| 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). |
Editorial Notes
16/05/2024: Internal review.
17/04/2024: Study's existence confirmed by Instituto de Salud Carlos III.
