E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Venous thromboembolic disease |
Enfermedad tromboembólica venosa |
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E.1.1.1 | Medical 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. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary 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). |
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E.5.1.1 | Timepoint(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.
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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.
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E.5.2 | Secondary 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.
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E.5.2.1 | Timepoint(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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
ningún tratamiento |
no treatment |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ningun tratamiento |
no treatment |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 19 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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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. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |