Screening for Cancer in Patients With Unprovoked VTE

Pulmonary Embolism Clinical Trial

— SOME-RIETE  

Official title:

PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03937583
• Other study ID #: SOME RIETE
• Secondary ID: 2018-003958-25
• Status: Recruiting
• Phase: Phase 4
• Start date: October 23, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Luis Jara Palomares, MD/PhD
• Phone: +34 955012144
• Email: luisoneumo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Embolism
• Pulmonary Disease
• Pulmonary Embolism
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Screening
• Thromboembolism
• Thrombosis
• Undefined
• Venous Thromboembolic Disease
• Venous Thrombosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
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	Fundació Hospital de L'Esperit Sant	Santa Coloma De Gramenet	Barcelona
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla	Seville
Spain	Hospital Universitari i Politècnic La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of neoplasms diagnosed in early phase using extended screening	Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in early phase in the screening process in patients with high-risk unprovoked thromboembolic disease.	After 3 years of follow-up
Secondary	Overall survival of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening	Estimate the impact of an active cancer search strategy using PET-CT in the overall survival in patients with high-risk unprovoked thromboembolic disease.	Until the patient death or finalization of study after three years of follow-up
Secondary	European Quality of Life-5 (EQ-5D scale validated in Spanish) of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening	Estimate the impact of an active cancer search strategy using PET-CT in the quality of life evaluated with the scale EQ-5D in patients with high-risk unprovoked thromboembolic disease. The EQ-5D consists of 2 parts - the "Descriptive System" and the "Visual Analogue scale". The DS comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.; The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.	Baseline and after 90, 180 and 365 days of follow-up