INFORMATII GENERALE

 

Titlu proiect complex: “Dezvoltarea de radiofarmaceutice si tehnici nucleare in oncologie pentru imagistica si tratament personalizat la nivel molecular”

Acronimul proiectului:ONCORAD

Responsabil Proiect Institutul Clinic Fundeni: CSI Dr. Simona Olimpia Dima

Competiția: „Proiecte Complexe realizate în consorții CDI” (PCCI), PN III, Programul 1, Subprogramul 1.2.

Autoritatea contractanta:Unitatea Executiva pentru Finantarea Invatamantului Superior, a Cercetarii, Dezvoltarii si Inovarii (UEFISCDI)

Cod proiect:PN-III-P1-1.2-PCCDI- 2017-0769

Numar contract:64PCCDI/30.04.2018

Coordonator:Institutul National De Cercetare – Dezvoltare pentru Fizica si Inginerie Nucleara “Horia Hulubei “- IFIN – HH

Valoare totala a contractului:5,287,500 lei

Bugetul alocat pentru Institutului Clinic Fundeni: 381,836 lei

Durata proiect:30.04.2018 – 30.09.2020

PARTENERI

Institutii partenere in proiect:

Instituția coordonatoare:  Institutul National de Cercetare si Dezvoltare pentru Fizica si Inginerie Nucleara “Horia Hulubei” (IFIN-HH) Director Proiect:Dr. Mihai Ciubotaru

P1 –Institutul de Biochimie al Academiei Romane (IBAR)

P2 – Institutul National de Cercetare Medico-Militara “Cantacuzino” (IC) – Partener 2

P3 – Universitatea Bucuresti (UB)

P4 – Institutul National de Cercetare-Dezvoltare in Domeniul Patologiei si Stiintelor Biomedicale “Victor Babes” (IVB)

P5 – Institutul National de Cercetare-Dezvoltare pentru Tehnologii Izotopice si Moleculare (INCDTIM)

P6 – Universitatea de Medicina si Farmacie “Carol Davila” (UMFCD)

P7 – Institutul Clinic Fundeni (ICF) Responsabil partener: CSI Dr. Simona Olimpia Dima

OBIECTIVE

Obiectivul general al proiectului ONCORAD este cresterea capacitatilor institutionale ale partenerilor proiectului destinat dezvoltarii de radiofarmaceutice si tehnici nucleare in oncologie, precum si utilizarea acestora in imagistica si tratament personalizat la nivel molecular. Institutia coordonatoare IFIN-HH, un centru de referinta in fizica nucleara la nivel european va spori prin acest consortiu apropierea cercetarilor deja existente din domeniul radiobiologiei si radiofarmaceutic de orientarea moleculara a medicinii modern personalizate in oncologie.

Proiectul 4: Coordonator: Institutul Clinic Fundeni, Responsabil: CSI Dr. Simona Olimpia Dima

Obiectivul major al acestui proiect este de a dezvolta o tehnologie inovativa prin combinarea originala a unui panel de biomarkeri promitatori: numarul micronucleilor radioindusi; numarul focarelor γ-H2AX radioinduse; profilul expresiei genice a genelor radiosensibile implicate in repararea leziunilor genetice (XRCC1,XRCC3, ATM, HAP1, TP53, CDKN1A, RAD9A, PTTG1, LIG3, MAD2L2) din probe de sange pentru predictia efectelor toxice clinice asupra pacientilor cu carcinom mamar si din sfera ORL supusi radioterapiei. Acesti posibili markeri moleculari vor fi masurati pe probe relevante prelevate de la pacienti inainte de tratament (prin radioterapie externa) si supuse iradierii in vitro (cu radiatii ionizante din surse externe-raze X si interne-radiofarmaceutice) pentru aprecierea radiosensibilitatii individuale in vitro. Apoi se va realiza corelarea incidentei efectelor acute secundare (radiosensibilitate clinica, in vivo) in radioterapia pacientilor cu parametrii de radiosensibilitate obtinuti prin teste in vitro (cu radiatie X). Astfel, se va testa puterea de predictie a biomarkerilor propusi. Acest model va fi validat prin utilizare de radionuclizi de diagnostic si terapie ca sursa de iradiere in vitro. Din cate stim, este primul studiu in care se va face o corelare a radiosensibilitatii in vitro prin utilizare atat a tratamentului cu raze X cat sia radiofarmaceuticelor.

Proiectul nostru care are o abordare multiparametrica prevede urmatoarele obiective specifice:

  • Testarea valorii fiecarui biomarker de predictie a efectelor clinice adverse; Pentru definirea radiosensibilitatii individuale in vitro vor fi testati biomarkerii amintiti mai sus.
  • Dezvoltarea unui model predictiv (prin integrarea tuturor biomarkerilor promitatori ) pentru radiosensibilitatea clinica individuala care va permite stratificarea pacientilor, personalizarea tratamentului si chiar orientarea catre un alt tip de tratament;
  • Validarea acestui model prin utilizarea ca sursa de iradiere in vitro a radionuclizilor de diagnostic si terapie obtinuti in Proiectul 2al acestui consortiu;
  • Crearea unei biobanci de probe biologice relevante de la pacientii radiosensibili, care va fi deschisa pentru investigarile din domeniu;
  • Crearea unei baze de date care sa contina informatii epidemiologice, detalii ale tratamentului, efecte secundare, informatii

Proiectul propus are potentialul de a imbunatati calitatea vietii pacientilor bolnavi de cancer si de a reduce costurile necesare pentru ingrijirea medicala post-tratament.

GENERAL INFORMATION

 

Complex project title: “Development of radiopharmaceutics and nuclear techniques in oncology form imagistic studies and personalized treatment at the molecular level”

Project acronym: ONCORAD

Project coordinator from Fundeni Clinical Institute: CSI Dr. Simona Olimpia Dima

Competition:“Complex projects completed in consortia CDI” (PCCI), PN III, Program 1, Subprogram 1.2.

Contracting Authority: Executive Unit for Financing Higher Education, Research, Development and Innovation (UEFISCDI)

Project code:PN-III-P1-1.2-PCCDI- 2017-0769

Contract number:64PCCDI/30.04.2018

Total contract value:5,287,500 lei

Total budget for Fundeni Clinical Institute:381,836 lei

Project duration:30.04.2018 – 30.09.2020

PARTNERS

 

Partner institutions:

Project coordinator: “Horia Hulubei”National Institute of Physics and Nuclear Engineering(IFIN-HH) – Project director: Dr. Mihai Ciubotaru

P1-Institute of Biochemistry of the Romanian Academy (IBAR)

P2-“Cantacuzino” National Military Medical Institute for Research-Development (IC) – Partner 2

P3-University of Bucharest (UB) – Partner 3

P4-“Victor Babes”National Institute of Pathology and Biomedical Sciences (IVB) – Partner 4

P5-National Institute for Research and Development of Isotopic and Molecular Technologies (INCDTIM) – Partner 5

P6-“Carol Davila” University of Medicine and Pharmacy (UMFCD) – Partner 6

P7-Fundeni Clinical Institute (FCI) – Partner 7, Partner team leader: CSI Dr. Simona Olimpia Dima

OBJECTIVES

 

The general objective of the ONCORAD project is the development of the institutional capacity for research and development of the project partners, specifically in the field of radio-pharmaceutics and nuclear techniques in oncology, as well as their use in imagistic studies and molecular based personalized treatment. The coordinating institution, IFIN-HH, a reference centre in nuclear physics at a European level will increase, through this consortium, the interconnection of already existing research in the fields of radiobiology and radio- pharmaceutics, as well as in personalized medicine in oncology.

Project 4, Coordinator: Fundeni Clinical Institute, CSI Dr. Simona Olimpia Dima.

The main objectiveof this project is to develop an innovative technology by combining a promising panel of biomarkers: number of radio-induced micronuclei, number of radio-induced γ-H2AX foci, gene expression profile of genes involved in the repair of genetic lesions (XRCC1, XRCC3, ATM, HAP1, TP53, CDKN1A, RAD9A, PTTG1, LIG3, MAD2L2) from blood samples to predict clinical toxic effects of radiotherapy in patients with breast cancer and head and neck cancers. These possible molecular biomarkers will be evaluated on samples from patients both before treatment (through external radiotherapy) and after in vitroirradiation (with ionizing radiation from external sources – X rays and internal sources – radiopharmceutics) to determine individual in vitroradiosensibility. Furthermore, we will corelate the incidence of acute side effects (clinical in vivoradiosensibility) from radiotherapy with radiosensibility parameters obtained from in vitro tests. As such, we will test the prediction power of the proposed biomarkers.

Our model will be validated by using diagnosis and therapy radionuclide as an in vitroradiation source. As far as we know, this is the first studywhich will corelate in vitro radiosensibility with both X ray and radiopharmaceutics treatment.

Our project has the following specific objectives:

  • Testing the predictive value of each biomarkers in regards to clinical side effects of radiotherapy.
  • Developing a prediction model for individual clinical radiosensibility which will allow for stratification of patients and treatment personalization
  • Validation of this model by using diagnosis and therapy radionuclide obtained in Project 2of this consortium
  • Creating a relevant biobank of samples from patients with radiosensibility, which will be open to other studies
  • Creating a database of epidemiological, treatment and side effects data.

This project has the potential to improve quality of life of cancer patientsand to reduce medical costs.