Screening for Cancer in Patients With Unprovoked VTE
SOME-RIETE
PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.
2 other identifiers
interventional
650
1 country
17
Brief Summary
Open and multicenter randomized clinical trial (1:1) comparing limited screening with extended screening with the performance of Positron emission tomography-computed tomography (PET-CT) scan in the search for neoplasms in patients with unprovoked venous thromboembolic disease at high risk of developing cancer at follow-up. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2019
Longer than P75 for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
October 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 9, 2021
November 1, 2021
4.1 years
April 30, 2019
November 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of neoplasms diagnosed using extended screening
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.
After 3 years of follow-up
Secondary Outcomes (3)
Number of neoplasms diagnosed in early phase using extended screening
After 3 years of follow-up
Overall survival of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening
Until the patient death or finalization of study after three years of follow-up
European Quality of Life-5 (EQ-5D scale validated in Spanish) of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening
Baseline and after 90, 180 and 365 days of follow-up
Study Arms (2)
Limited screening
NO INTERVENTIONComplete clinical history, along with routine physical, analytical examination (creatinine, sodium, potassium, red series, white series, liver and calcium profile) and chest x-ray.
Extended screening
EXPERIMENTALLimited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Over 18 years.
- 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
You may not qualify if:
- Impossibility to continue an adequate follow-up.
- Contrast hypersensitivity used for PET / CT (fludeoxyglucose (18FDG)) or any of the excipients according to the characteristics of the product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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, 41013, 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
Related Publications (1)
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.
PMID: 39971173DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Jara Palomares, MD/PhD
Hospitales Universitarios Virgen del Rocío
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2019
First Posted
May 6, 2019
Study Start
October 23, 2019
Primary Completion
December 1, 2023
Study Completion
December 31, 2023
Last Updated
December 9, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 3 years time
- Access Criteria
- In order to access the data, the study must first be completed, the database must be closed, and analyzed. Once the manuscript is written, the results will be sent to the participating centers, and study data may be requested upon request to the principal investigator who will evaluate together with the study investigators.
IPD to be shared with the center participants once the study is officially finished in the foreseen period of three years.