Abstract CN59
Background
Biomarker identification and validation is one of the greatest challenges in cancer research and it fully depends on the ability to obtain biological samples and clinical data from patients meeting all legal, ethical and quality requirements. We have developed a Translational Research Unit coordinated autonomously by Nursing which allows obtaining biological samples and associated clinical data from patients. Here, we report the activity and outcomes of our Translational Research Unit.
Methods
We developed a global protocol for collecting samples and clinical data from patients and healthy controls using a universal informed consent, in collaboration with the Ethics Committee, the Biobank and the Biochemistry, Pathology, Pneumology and Oncology Departments. Patients, managed in the routine care setting and in clinical trials, authorize the collection of blood and urine samples and clinical data for research purposes; and to study their biopsies and other samples (e.g.: ascitic fluid, etc.) obtained for healthcare purposes, as long as it does not interfere with their clinical management. Samples are obtained at baseline, at the time of reassessments (CT, PET,...) and at other clinically relevant times. Blood samples are drawn simultaneously with routine analyses.
Results
Between February 2009 and May 2024 we obtained blood samples from more than 7,600 patients, many of them sequential. Molecular studies, including genomic, RNA and protein expression and immunological profiling among others, have been performed on the samples, resulting on 140 studies published in international journals, 92 research grants and contracts funded with over 18 million €, 19 doctoral thesis, and 7 patents. Table: CN59
ACTIVITY | N | FUNDING (€) |
Samples | 7,600 | - |
Manuscripts | 140 (Q1: 118 (84%); top decile: 62 (44%)) | - |
Biomarker research projects | 45 | 8,647,835 |
Global research projects including biomarkers | 15 | 5,547,273 |
Grants for Academic Clinical Trials incorporating biomarkers | 22 | 3,061,618 |
Research contracts | 10 | 910,555 |
Doctoral Thesis | 19 | - |
Master and Degree Projects | 5 | - |
Patents | 7 | - |
Total funding | 18,167,282 € |
Conclusions
Translational Research Units are the cornerstone for biomarker development, allowing to collect and study biological samples from cancer patients and to perform high quality research projects. Nursing has a fundamental role in coordinating Translational Research Units.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
I. Melero: Financial Interests, Personal, Advisory Board: Agneus, Alligator Bioscience, AstraZeneca, BMS, BioLineRx, Boehringer Ingelheim, Boston Pharma, CRISPR Therapeutics, CatalYm GmbH, Crescendo Biologics, Curon Biopharmaceutical, EMD Serono, F-Star, Genentech, Genmab, Gossamer Bio, Highlight Therapeutics, Hookipa Pharma, HotSpot Therapeutics, Inc., ImmuneSensor Therapeutics, Inc., Janssen, MSD, Merus N.V., Monopteros Therapeutics, Noxxon Pharma AG, Numab, Phenomic Bio, Pieris Pharmaceuticals GmbH, Pierre Fabre, Roche, Sanofi, Senti Biosciences, Servier, Shattuck Labs, Third Rock Ventures; Financial Interests, Personal, Other, Consultant: PharmaMar; Financial Interests, Institutional, Coordinating PI: AstraZeneca, Roche, BMS, Genmab, Alligator. J.L. Perez Gracia: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: MSD, Astellas; Financial Interests, Institutional, Coordinating PI, Research grant: Roche; Financial Interests, Institutional, Local PI: BMS, Amgen, Astellas, Novartis; Financial Interests, Institutional, Coordinating PI: Seattle Genetics; Financial Interests, Personal, Funding: Roche. All other authors have declared no conflicts of interest.
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