NCT03937583: SOME-RIETE

Screening for Cancer in Patients With Unprovoked VTE

Status unknown Phase 4 Last updated 9 December 2021

What this trial tests

Phase 4 trial testing Fludeoxyglucose 18F in Venous Thromboembolic Disease in 650 participants. Status unknown.

Timeline

23 October 2019

Primary endpoint
1 December 2023

31 December 2023

Quick facts

Lead sponsor	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	650
Start date	23 October 2019
Primary completion	1 December 2023
Estimated completion	31 December 2023
Sites	17 locations across Spain

Drugs / interventions tested

• Fludeoxyglucose 18F — full drug profile →

Conditions studied

• Venous Thromboembolic Disease — all drugs for Venous Thromboembolic Disease →
• Respiratory Disease — all drugs for Respiratory Disease →
• Pulmonary Disease — all drugs for Pulmonary Disease →
• Deep Venous Thrombosis — all drugs for Deep Venous Thrombosis →

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla — full company profile →

Who can join

18 and older, any sex, with Venous Thromboembolic Disease or Respiratory Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of testing for cancer on cancer- or venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE.
   Robertson L, Broderick C, Yeoh SE, Stansby G. · · 2021 · cited 10× · PMID 34597414 · DOI 10.1002/14651858.cd010837.pub5
2. Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial.
   Barca-Hernando M, Otalora-Valderrama S, Lopez-Nuñez JJ, Portillo-Sanchez J, et al · · 2025 · cited 3× · PMID 39971173 · DOI 10.1016/j.ahj.2025.02.004