Gastrointestinal cancer: colorrectal adenocarcinoma, gastroesophageal adenocarcinoma, pancreatic adenocarcinoma Cancer
Conditions
Interventions
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 year
Sponsors
Navarre Institute of Health Research
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 U | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison between each tumor type, and pan-tumor between sexes using primary outcome measure data as above. | — |
Countries
Spain
Contacts
Public ContactMaria Alsina
Outcome results
None listed