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Translation into Clinical Practice

Implementation of cost-effective alternatives and advancements in diagnostic and therapeutic processes

PI GROUP
Carmina Díaz [GIN]: 1 Neurosciences Research
TITLE Intramuscular infusion of autologous bone marrow-derived stem cells in patients with Amyotrophic Lateral Sclerosis
YEAR 2019-2022
REFERENCE PROJECT/PUBLICATION TCIM – ELA II. EudraCT number: 2019-002302-46
DESCRIPTION Intramuscular stem cell infusion to prolong the survival of anterior horn motor neurons. Trial funded by the ISCIII, sponsored by FFIS-IMIB. Application of knowledge derived from experimental studies on cell therapy in ALS models at the Alicante Neuroscience Institute.
IMPLEMENTATION/IMPACT Phase II multicenter clinical trial
TITLE

Validation and optimization of alpha-synuclein (α-syn) determination in cerebrospinal fluid as a biomarker for the early and differential diagnosis of Alzheimer’s disease versus synucleinopathies.

J Neurochem 150:218-230 (2019)

AÑO 2019
REFERENCE PROJECT/PUBLICATION DG for Universities, Research and Science, GVA (AICO/2018/090 to JSV), CIBERNED, ISCIII (FEDER, ‘Investing in your future’).
DESCRIPTION Improvement in the differential diagnosis at the mild cognitive impairment stage in patients with Alzheimer’s disease compared to patients with Lewy body dementia.
IMPLEMENTATION/IMPACT Redesign of ELISA protocols for the determination of α-syn in the CSF, design of alternative kits for differential diagnosis.
PI GROUP
Jesús Vioque [GIN]: 35 Nutritional Epidemiology
TITLE

Food Frequency Questionnaires (FFQ)

PLOS ONE | DOI:10.1371/journal.pone.0167338

Nutrients 2019, 11, 933; doi:10.3390/nu11040933

YEAR 2019
PROYECTO/PUBLICACIÓN DE REFERENCIA Red INMA G03/176; CB06/02/0041; FIS 97/0588; 00/0021-2, PI061756; PS0901958; FIS-FEDER 03/1615, 04/1509, 04/1112, 04/1931, 05/1079, 05/1052, 06/1213, 07/0314; 09/02647; FIS-PI041436, FIS- PI081151, FIS-PI06/0867; FIS-PS09/00090, FIS-PI042018, FIS-PI09 02311, FIS PI11/01007, FISPI13/02429, FISPI16/1288, FISPI17/00260), Fundació la Marato TV3 (201622 10), Miguel Servet-FEDER CP15/0025, FPU14/00046.
DESCRIPTION Validación de cuestionarios FFQ para la evaluación dietética de una amplia gama de nutrientes y grupos de alimentos en población pediátrica (cohorte INMA)
IMPLEMENTATION/IMPACT Registro y licencia de uso
PI GROUP
Joaquín Portilla [GIN]: 2 Infectious Diseases Research

PI GROUP
Luis Hernández [GIN]: 7 Translational Research in Respiratory Diseases

PI GROUP
Francisco Javier Pérez [GIN]: 13 Nephrology Research

PI GROUP
Isabel Betlloch [GIN]: 18 Research in Medical-Surgical Dermatology

PI GROUP
Luis Moral [GIN]: 38 Research in Pediatrics and Clinical Pharmacology
TITLE ANAMNESIS INTERVIEW FOR THE DETECTION OF AUTISM SPECTRUM DISORDERS (ASD)
YEAR 2019
REFERENCE PROJECT/PUBLICATION Trastea: Comprehensive Care Document for Autism Spectrum Disorder.
DESCRIPTION Incorporation of specific content into the general anamnesis interview to be conducted by “front-line professionals” (Primary Care pediatricians). This content is designed to identify indirect signs of ASD during early developmental stages, thereby streamlining the diagnosis following referral to the appropriate specialist.
IMPLEMENTATION/IMPACT Currently in the implementation phase. Incorporated into the PIR (Resident Intern Psychologist) training program of the Pediatric Psychology Unit.

 

PI GROUP
Paloma Vela [GIN]: 16 Research in Musculoskeletal System Pathology
TITLE

EVALUATION OF THE IMPLEMENTATION OF ASSOCIATED RISK MANAGEMENT RECOMMENDATIONS

FOR THE USE OF BIOLOGIC THERAPIES IN THE RHEUMATOLOGY DEPARTMENT OF THE ALICANTE GENERAL

UNIVERSITY HOSPITAL: FIVE-YEAR FOLLOW-UP AFTER THE FIRST EVALUATION

YEAR 2019-2021 (in progress)
REFERENCE PROJECT/PUBLICATION 6th Call for Grants to Support and Promote Research, ISABIAL 2019
DESCRIPTION To evaluate the outcome of implementing a vaccination programme 5 years ago in patients receiving biologic drugs with incomplete or absent vaccination. Also, to compare the vaccination status of patients to whom improvement measures were applied with the vaccination status of patients diagnosed and treated subsequently.
IMPLEMENTATION/IMPACT In progress (comparing the new results with those from 5 years ago).
TITLE DETECTION OF DEFICITS IN RISK CONTROL IN CHRONIC ARTHRITIS THROUGH THE IMPLEMENTATION OF A NURSE-LED PROGRAMME
YEAR 2019-2021 (in progress)
REFERENCE PROJECT/PUBLICATION 6th Call for Grants to Support and Promote Research, ISABIAL 2019
DESCRIPTION

– Quantify and identify deficiencies in risk control in patients with chronic arthritis treated with biologic drugs in routine clinical practice, through the implementation of a nurse-led programme in rheumatology clinics.

– Evaluate the actions undertaken by the rheumatologist after applying the programme.

– Evaluate the programme’s effectiveness one year after its implementation

IMPLEMENTATION/IMPACT Implementation of a nursing programme that makes it possible to correct deficits that exist in clinical practice, in routine medical consultations, both in risk control and in the detection and management of comorbidities. It will improve the management of these patients, their safety and, consequently, provide higher-quality care.
TITLE BIOBADASER Phase III
YEAR 2015–in progress
REFERENCE PROJECT/PUBLICATION FER-ADA-2015-01
DESCRIPTION BIOBADASER Phase III is a prospective follow-up study of adverse events and safety in biologic and biosimilar treatments in patients with rheumatologic diseases
IMPLEMENTATION/IMPACT This study will make it possible to identify adverse events that occur during the treatment of rheumatic diseases with biologic therapies and biosimilar medicines, estimate their frequency, identify unexpected adverse events, and identify adverse events that occur after treatment discontinuation.
TITLE Cardiovascular and extension ultrasound evolution in new patients with gout
YEAR 2019–ongoing
REFERENCE PROJECT/PUBLICATION

UGP-18-043

Research Support Grant in Rheumatology from the Valencian Rheumatology Foundation (FVR) 2018

RESEARCH PROMOTION PLAN. FER GRANTS 2017 (Spanish Foundation of Rheumatology)

DESCRIPTION Study aimed at conducting a prospective cardiovascular ultrasound assessment of new patients with gout
IMPLEMENTATION/IMPACT This study aims to prospectively evaluate patients with gout from the perspective of carotid ultrasound atherosclerosis, seeking to establish the impact of gout treatment itself and its consequences (crystal dissolution) on such evolution. The results may potentially confirm the cardiovascular benefit of appropriate gout management, which to date remains controversial.

PI GROUP
Rodrigo Jover [GIN]: 6 Colorectal Cancer Research: Prevention and Management
TITLE Definition of diagnostic criteria in Lynch-like syndrome
YEAR 2013-2019
REFERENCE PROJECT/PUBLICATION Rodríguez-Soler Gastroenterology 2013; Picó Clin Gastroenterol Hepatol 2019
DESCRIPTION Definition of a new familial risk entity, characterised by the presence of colorectal cancer with suspected Lynch syndrome not confirmed by genetic testing
IMPLEMENTATION/IMPACT Surveillance strategies under the diagnostic criteria of the new entity
TITLE Post-polypectomy surveillance algorithm
YEAR 2012-2019
REFERENCE PROJECT/PUBLICATION Atkin Endoscopy 2012; Hassan Endoscopy 2013; Mangas-Sanjuan Gastroenterol Hepatol 2019
DESCRIPTION Participation in European and national clinical practice guidelines that define the surveillance algorithm after removal of colon polyps
IMPLEMENTATION/IMPACT Participation in and leadership of past and current post-polypectomy surveillance algorithms in our country

PI GROUP
Enrique de-Madaria [GEM]: 25 Clinical Research in Pancreatology

PI GROUP
Celia Villodre [GEM]: 32 Surgical Audit Research
TITLE

Risk scales for morbidity in community-acquired emergency gastrointestinal surgery. Comparison between open and laparoscopic approaches. Prospective, multicentre Spanish study.

Am J Surg. 2016 Nov;212(5):917-926

YEAR In progress (2017-2019)
REFERENCE PROJECT/PUBLICATION

LUCENTUM

Alicante Surgical Community Emergencies New Tool for the enUmeration of Morbidities: a simplified auditing tool for community-acquired gastrointestinal surgical emergencies.

DESCRIPTION LUCENTUM is intended to be used as a tool for conducting surgical audits. It provides population adjustment according to the risk of morbidity and mortality. The main objective is to define risk-adjusted benchmark outcomes that make it possible to adopt measures to improve quality of care.
IMPLEMENTATION/IMPACT In progress (comparing the new results with benchmark standards).
PI GROUP
Gloria Peiró [GCL]: 9 Breast Cancer Research
TITLE Determination of biomarkers for stratifying patients at risk of death or local/distant recurrence, treatment response (trastuzumab, paclitaxel), and therapeutic targets
YEAR In progress (2006-2019)
REFERENCE PROJECT/PUBLICATION

1. Insulin-like growth factor 1 receptor (IGF-IR) and PTEN in patients with T1-2N0M0 breast cancer treated with breast-conserving therapy and radiotherapy. Correlation with local response and prognostic value (FIS 03/1411)

2. Predictive value of response to trastuzumab of growth factors and the PI3K/Akt signalling pathway in HER2+ breast cancer (FIS 06/1495)

3. Retrospective analysis of the PTEN/PI3K/Akt pathway and response to paclitaxel in early breast cancer with positive lymph nodes (FIS 06/1488)

4. Osteopontin-C: prognostic and/or predictive marker of response to trastuzumab in patients with HER2-positive breast cancer? FCVI-HGUA (2008-09)

5. Study of the expression of factors in the Hedgehog signalling pathway in cell lines representative of breast cancer immunophenotypes. FCVI-HGUA (2012/PC-08)

6. Inhibitor of Differentiation proteins (IDs): study of their regulatory function as biomarkers of “tumour stem cells” and of epithelial–mesenchymal transition in breast cancer. BIENVENIDA NAVARRO-LUCIANO TRIPODI FOUNDATION. 2016 (BOLA00150)

7. Immunity and breast cancer (IN PROGRESS):

.- Analysis of immune checkpoints in co-cultures of breast cancer cell lines and mononuclear cells: pilot study. ISABIAL/FISABIO 2018 (NR-180172); 2018 (NR-180184)

.- Relevance of immune checkpoints as biomarkers in breast cancer and their correlation with clinico-pathological factors. ISABIAL/FISABIO 2019 (NR-190292)

.- Relevance of immune checkpoints as biomarkers in breast cancer and their correlation with clinico-pathological factors. 2019 (NR-190293)

DESCRIPTION Studies of protein, RNA and mutational expression of IGF1R, PTEN/PI3K/Akt/mTOR, c-SRC, osteopontin, inhibitor of differentiation proteins (ID), FOXP3 and regulatory T cells (Treg), immune checkpoints
IMPLEMENTATION/IMPACT In progress (applicability as “therapeutic targets” in the context of Clinical Trials)
PI GROUP
Juan Carlos Martínez [GCL]: 19 Gynaecological Neoplasms Research
PI GROUP
José Bañuls [GCL]: 21 Melanoma Research
PI GROUP
F. Javier Fernández Sánchez [GCL]: 11 Drug Allergy Research
TITLE Beta-lactam Allergy in Elderly Patients
YEAR In progress since 2016
REFERENCE PROJECT/PUBLICATION Teodorikez Wilfox Jimenez Rodriguez; Natalia Blanca Lopez; Maria Ruano Zaragoza; Victor Soriano Gomis; Angel Esteban Rodriguez; Geronima Riera Sendra; Antonio Palazon Bru; Miguel Blanca; Jose Manuel Ramos Rincon; Javier Fernandez Sanchez. Allergological Study of 565 Elderly Patients Previously Labeled as Allergic to Penicillins. Journal of Asthma and Allergy. 12, pp. 421 – 435. 26/12/2019.
DESCRIPTION Study of allergic reactions to penicillins in patients aged 60 years and older, to assess true reactivity and immunosenescence, as well as cost reduction by avoiding the penicillin allergy label.
IMPLEMENTATION/IMPACT Daily study of elderly patients and currently any patient over 14 years of age who is admitted to hospital for any condition and has the label or indicates that they have a penicillin allergy.
TITLE Determination of clinical criteria and biomarkers for the study of non-IgE-mediated food allergy (in English, Food protein-induced enterocolitis syndrome, FPIES)
YEAR In progress since 2012
REFERENCE PROJECT/PUBLICATION

1. González-Delgado P, Caparrós E, Moreno MV, Clemente F, Flores E, Velásquez L, Rubio G, Fernández J. Clinical and immunological characteristics of a pediatric population with food protein-induced enterocolitis syndrome (FPIES) to fish. IF: 3,775. Pediatr Allergy Immunol. 2016 May;27(3):269-75. doi: 10.1111/pai.12529.

2. Moreno MV, Caparrós E, Fernández J, González-Delgado P. Immunologic study of two fruit-induced FPIES cases. Pediatr Allergy Immunol 2017 Aug 8.doi:10.1111/pai.12769.

3. Purificación Gonzalez-Delgado, Esther Caparrós, M. Victoria Moreno, Begoña Cueva, and Javier Fernández. Food protein induced enterocolitis-like syndrome in a population of adolescents and adults caused by seafood. J Allergy Clin Immunol Pract. 2019 7(2):670-672. doi: 10.1016/j.jaip.2018.07.028 PMID: 30075344

DESCRIPTION Clinical studies on the characteristics of FPIES, in both children and adults, and with foods other than those usually involved
IMPLEMENTATION/IMPACT Expanding knowledge of diseases within the spectrum of non-IgE-dependent food-related allergic diseases that affect a large number of people and are underdiagnosed.
GROUP TITLE YEAR REFERENCE PROJECT/PUBLICATION DESCRIPTION IMPLEMENTATION/IMPACT
What has been the impact of the results? Has it been implemented in clinical practice, and how?
GROUP 1 Creation of the spin-off company Tearful, S.L. 2020 Creation of a UMH spin-off company Company activity: development of diagnostic equipment (patent application P201931176, 2019-12-30)
GROUP 11 DESENSITISATIONS TO CHEMOTHERAPEUTIC AGENTS 2020 Jimenez-Rodriguez TW; Berges-Gimeno M; Barranco R; et al;Muñoz-Cano R. 2021. Management of hypersensitivity reactions to chemotherapy and biologic agents: A survey of ARADyAL (Asthma, Allergic and Adverse Reactions Network) Desensitisations to biologics and chemotherapeutic agents
GROUP 11 DELABELLING OF PENICILLIN ALLERGY 2020-21 TW Jimenez-Rodriguez; Natalia Blanca-Lopez; Maria Ruano-Zaragoza; et al; Javier Fernandez- Sanchez. 2019. Allergological Study of 565 Elderly Patients Previously Labeled as Allergic to Penicillins Journal of Asthma and Allergy. 12, pp.421-435. Delabelling of all patients admitted with a penicillin allergy alert in the hospital
GROUP 19 SENTINEL LYMPH NODE IN ENDOMETRIAL CANCER 2020 IdiPAZ HULP Study Code: PI-1460 Use of the sentinel lymph node as an intraoperative diagnostic procedure. High impact. YES, IT HAS BEEN IMPLEMENTED IN PRACTICE.
GROUP 19 Randomised, open-label, parallel-group clinical trial with a control group to explore the efficacy of PALOMACARE gel in repairing the cervico-vaginal mucosa with lesions caused by HPV (PALOMA Clinical Trial) PHPC-201501 Use of Papilocare Gel as an adjuvant in the treatment of certain preneoplastic lesions
GROUP 19 Multicentre study
to evaluate the diagnostic utility of the intraoperative human papillomavirus test
as an early marker of cure or recurrence in women with high-grade cervical
intraepithelial neoplasia (HSIL/CIN2-3)
PR(AMI)131/2020 Sampling for the study of HPV presence at the time of conisation. It has been incorporated into practice as a prognostic assessment method and for follow-up.
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