Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
650 participants
INTERVENTIONAL
2019-10-23
2023-12-31
Brief Summary
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Introduction: Cancer screening in patients with unprovoked venous thromboembolic disease (VTE) is controversial. In the last years, a score has been developed that selects patients at high risk of developing cancer during follow-up.
Objective: To estimate the impact of an active cancer search strategy using 18-fluordesoxiglucose (FDG) PET-CT in unprovoked VTE with high-risk to develop cancer.
Specific Objectives: 1) Number of neoplasms diagnosed in the screening process: 2) number of neoplasms diagnosed at an early stage, 3) impact on survival of the strategy; and 4) impact on the quality of life.
Cancer will be considered from 30 days up to 12 months after the diagnosis of VTE.
Scope: 20 Spanish hospitals. Design: Open-label, multicentre Randomized clinical trial (1: 1) comparing the performance of PET-CT versus limited screening for cancer.
Population: Patients older than 18 years with unprovoked VTE at high risk of presenting cancer at follow-up (≥3 points in the score of Jara-Palomares et al., Chest 2017).
Follow-up: 12 months after VTE. Sample: The sample size calculated is 650 patients, to obtain a power of 80%, with a level of significance of 5%, and taking into account a 10% loss of follow-up.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Limited screening
Complete clinical history, along with routine physical, analytical examination (creatinine, sodium, potassium, red series, white series, liver and calcium profile) and chest x-ray.
No interventions assigned to this group
Extended screening
Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).
Fludeoxyglucose 18F
The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3-5 MBq / kg of 18FDG. Intravenous injection will follow a period of approximately 60 minutes in a quiet room.
Computed tomography (CT) will be performed from the middle of the forehead to the feet with normal and shallow breathing using a low dose adjustment Iodinated contrast will not be administered intravenously.
Interventions
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Fludeoxyglucose 18F
The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3-5 MBq / kg of 18FDG. Intravenous injection will follow a period of approximately 60 minutes in a quiet room.
Computed tomography (CT) will be performed from the middle of the forehead to the feet with normal and shallow breathing using a low dose adjustment Iodinated contrast will not be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of venous thromboembolic disease (proximal deep vein thrombosis of lower limbs, pulmonary embolism or both) unprovoked.
* High risk classification according to previously published and validated scale
* Signature of informed consent form
Exclusion Criteria
* Contrast hypersensitivity used for PET / CT (fludeoxyglucose (18FDG)) or any of the excipients according to the characteristics of the product.
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Luis Jara Palomares, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Locations
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Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Fundació Hospital de L'Esperit Sant
Santa Coloma de Gramenet, Barcelona, Spain
Hospital Universitario Virgen del Rocío
Seville, Seville, Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Vall d'Hebrón
Barcelona, , Spain
Consorcio Hospitalario Provincial de Castellón
Castelló, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital de Granollers
Granollers, , Spain
Clínica Universidad de Navarra
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Infanta Sofía
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario de Valme
Seville, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Juan José López Núñez, MD
Role: primary
Gloria de la Red Bellvis, MD
Role: primary
Luis Jara-Palomares, MD
Role: primary
Jesús Aibar Gallizo, MD
Role: primary
Marina Suarez Pinera, MD
Role: primary
Fátima del Molino Sanz, MD
Role: primary
Carmen Díaz Pedroche, MD
Role: primary
Alicia Lorenzo Hernández, MD
Role: primary
Vladimir Salazar Rosa, MD
Role: primary
References
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Barca-Hernando M, Otalora-Valderrama S, Lopez-Nunez JJ, Portillo-Sanchez J, Pagan-Escribano J, Lopez-Miguel P, Mahe I, Mena-Munoz E, Jou-Segovia I, Imbalzano E, Agudo-de Blas P, Lorenzo-Hernandez A, Diaz-Pedroche C, Aibar-Gallizo J, de la Red-Bellvis G, Del Molino-Sanz F, Amado-Fernandez C, Fernandez-Reyes JL, Villalobos-Sanchez A, Lopez-Saez JB, Diaz-Brasero AM, Marcos-Jubilar M, Meireles J, Marchena-Yglesias PJ, Diaz-Peromingo JA, Marin-Romero S, Elias-Hernandez T, Andrade-Ruiz HA, Mehdipour G, Bikdeli B, Jara-Palomares L; SOME-RIETE and ValRIETEs Investigators. Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial. Am Heart J. 2025 Jun;284:81-93. doi: 10.1016/j.ahj.2025.02.004. Epub 2025 Feb 17.
Other Identifiers
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2018-003958-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SOME RIETE
Identifier Type: -
Identifier Source: org_study_id