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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-003958-25
    Sponsor's Protocol Code Number:PI18/01097
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-003958-25
    A.3Full title of the trial
    Screening for cancer with PET / CT in patients with unprovoked venous thromboembolic disease with a high risk of developing cancer. Open randomized clinical trial.
    Detección del cáncer con PET/TAC en pacientes con enfermedad tromboembólica venosa no provocada con un alto riesgo de desarrollar cáncer. Ensayo clínico aleatorizado abierto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Screening for cancer with a very effective imaging technique to early tumors in patients with unprovoked venous thromboembolic disease with a slight risk of developing cancer. Open randomized clinical trial.
    Detección del cáncer con una técnica de imagen muy eficaz para detectar tumores precozmente en pacientes con enfermedad tromboenbolica venosa no provocada con un algo riesgo de desarrollar cáncer. Ensayo clínico aleatorizado abierto.
    A.3.2Name or abbreviated title of the trial where available
    Detección del cáncer con PET/TAC en pacientes con enfermedad tromboembólica venosa no provocada
    A.4.1Sponsor's protocol code numberPI18/01097
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPI18/01097 (ISCIII)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFISEVI
    B.5.2Functional name of contact pointUICEC-HUVR
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Manuel Siurot, s/n., Edif. de Laboratorios 6º planta
    B.5.3.2Town/ citySeville
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955013414
    B.5.6E-mailmariaa.lobo.exts@juntadeandalucia.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fludesoxiglucosa (18F)- IBA
    D.2.1.1.2Name of the Marketing Authorisation holderIBA PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFludesoxiglucosa (18F)
    D.3.4Pharmaceutical form Anticoagulant and preservative solution for blood
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUDEOXYGLUCOSE (18F)
    D.3.9.1CAS number 105851-17-0
    D.3.9.4EV Substance CodeSUB07680MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeFludeoxyglucose (18F) is indicated for use in obtaining images by positron emission tomography (PET) in patients with the possibility of having cancer
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Venous thromboembolic disease
    Enfermedad tromboembólica venosa
    E.1.1.1Medical condition in easily understood language
    The purpose of this study is to determine the effectiveness of the use of PET/CT to detect occult cancer in patients with venous thromboembolic disease vs. the diagnostic tests that are commonly used.
    Se pretende conocer la eficacia del uso de PET/TAC para detectar cáncer oculto en pacientes con enfermedad tromboembólica venosa vs. las pruebas de diagnostico que se utilizan habitualmente.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in the screening process in patients with high-risk unprovoked thromboembolic disease.
    Estimar el impacto de una estrategia de búsqueda activa de cáncer mediante PET-TAC en el número de neoplasias diagnosticadas en el proceso de cribado en pacientes con enfermedad tromboembólica no provocada de alto riesgo.
    E.2.2Secondary objectives of the trial
    To estimate the impact of an active cancer search strategy using 18DG PET-CT in:
    - Diagnosis of neoplasms in an early stage.
    - The impact on survival.
    - The quality of life.
    - Cost-effectiveness analysis of the tests carried out.
    Estimar el impacto de una estrategia de búsqueda activa de cáncer mediante 18DG PET-TAC en:
    - El diagnóstico de neoplasias en un estadio precoz.
    - En el impacto en supervivencia.
    - En la calidad de vida.
    - Análisis de coste-efectividad de las pruebas realizadas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Over 18 years.
    2. Diagnosis of venous thromboembolic disease (proximal deep vein thrombosis of lower limbs, pulmonary embolism or both) unprovoked.
    3. High risk classification according to previously published and validated scale (Jara-Palomares et al., Chest, 2016)
    4. Signature of informed consent.
    1. Mayores de 18 años.
    2. Diagnóstico de enfermedad tromboembólica venosa (trombosis venosa profunda proximal de miembros inferiores, embolia de pulmón o ambos) no provocado.
    3. Clasificación de alto riesgo según escala previamente publicada y validada (Jara-Palomares et al., Chest, 2016)
    4. Firma del consentimiento informado.
    E.4Principal exclusion criteria
    1. Impossibility to continue an adequate follow-up.
    2. Contrast hypersensitivity used for PET / CT (8-fluor deoxy-glucose (18FDG)) or any of the excipients according to the characteristics of the product.
    1. Imposibilidad de continuar un seguimiento adecuado.
    2. Hipersensibilidad al contraste utilizado para la realización del PET/TAC (8-fluor desoxi-glucosa (18FDG)) o a cualquiera de los excipientes de acuerdo a las características del producto.
    E.5 End points
    E.5.1Primary end point(s)
    Number of neoplasms diagnosed by limited screening histology vs. extended (with PET/CT).
    Número de neoplasias diagnosticadas mediante histología de cribado limitado vs. extendido (con PET/TAC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cancer diagnosis will be considered as cancer diagnosed from 30 days up to 12 months after the diagnosis of venous thromboembolic disease and with histological diagnosis.
    El diagnóstico de cáncer se considerará como diagnóstico de cáncer desde 30 días hasta 12 meses después del diagnóstico de enfermedad tromboembólica venosa y con diagnóstico histológico.
    E.5.2Secondary end point(s)
    - Recurrent ETV confirmed by imaging tests
    - Death
    - Lost in the follow-up
    - Health expenditure of complementary tests to which the patients have been subjected.
    - ETV recurrente confirmado mediante pruebas de imagen
    - Muerte
    - Perdido en el seguimiento
    - Gasto sanitario de pruebas complementarias a las que han sido sometidos los pacientes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Recurrent ETV confirmed by image tests, whether it is positive or negative and also the location.
    - Cause of the death of the patient since he enters the study until this happens.
    - Since the patient enters the study until he loses the tracking after a few months of testing.
    - Health expenditure of complementary tests to which the patients have been subjected: as a routine analysis, chest x-ray or ultrasound.
    - ETV recurrente confirmado mediante pruebas de imagen, tanto si es positivo o negativo y también la localización.
    - Causa de la muerte del paciente desde que entra en el estudio hasta que esto ocurriera.
    - Desde que el paciente entra en el estudio hasta que se le pierde el seguimiento pasados unos meses de las pruebas.
    - Gasto sanitario de pruebas complementarias a las que han sido sometidos los pacientes: como análisis de rutina, radiografía de tórax o ecografía.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    ningún tratamiento
    no treatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    ningun tratamiento
    no treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned19
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be considered the day of the last visit of the last patient included in the study or according to the Declaration of Helsinki, patients have the right to withdraw from the study at any time and for any reason, being able to express it personally or through their representative.
    Se considerará final del ensayo el día de la visita final del último paciente incluido en el estudio o de acuerdo con la Declaración de Helsinki, los pacientes tienen derecho a retirarse del estudio en cualquier momento y por cualquier motivo, pudiéndolo expresar personalmente o a través de su representante.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 650
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The signature of the consent can be given through a legal representative as long as the patient can accept their participation, know and understand the purpose of the trial.
    La firma del consentimiento informado puede darse mediante un representante legal siempre y cuando el paciente sea capaz de aceptar su participación, conozca y entienda la finalidad del ensayo.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state650
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All patients will undergo clinical follow-up at 3, 6 and 12 months. All the patients included will be instructed to contact the coordinator of their center. In case of suspicion of cancer or recurrence of venous thromboembolic disease, histological confirmation or objective imaging test will be required, respectively.
    Todos los pacientes serán sometidos a un seguimiento clínico a los 3, 6 y 12 meses. A todos los pacientes incluidos se le instruirá para contactar con el coordinador de su centro. En caso de sospecha de cáncer o de recurrencia de la enfermedad tromboembólica venosa se requerirá confirmación histológica o prueba de imagen objetiva, respectivamente.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation UICEC - HUVR
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-19
    P. End of Trial
    P.End of Trial StatusOngoing
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