Screening for Cancer in Patients With Unprovoked VTE (SOME-RIETE)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Unknown; Phase 4

Conditions: Pulmonary Embolism; Screening; Deep Venous Thrombosis; Respiratory Disease; Pulmonary Disease; Undefined; Venous Thromboembolic Disease

Treatments: Drug: Fludeoxyglucose 18F

Study type: Interventional

Funder types: Other

Identifiers

NCT03937583

2018-003958-25 (EudraCT Number)

SOME RIETE

Details and patient eligibility

About

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.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

Limited screening

No Intervention group

Description:

Complete 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

Experimental group

Description:

Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).

Treatment:

Drug: Fludeoxyglucose 18F