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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease; Pulmonary Embolism; Deep Venous Thrombosis; Respiratory Disease; Venous Thromboembolic Disease; Screening; Undefined
• Intervention / Treatment: Drug: Fludeoxyglucose 18F

• Study Type: Interventional
• Enrollment (Anticipated): 650
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Luis Jara Palomares, MD/PhD; Phone Number: +34 955012144; Email: luisoneumo@hotmail.com
• Study Contact Backup: Name: Clara M Rosso Fernández, MD/PhD; Phone Number: +34955012144; Email: claram.rosso.sspa@juntadeandalucia.es

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Del Mar
    • Contact: Marina Suarez Pinera, MD
    • Sub-Investigator: Diego Agustin Rodríguez, MD
  • Barcelona, Spain
    • Recruiting
    • Hospital Clínic de Barcelona
    • Contact: Jesús Aibar Gallizo, MD
  • Barcelona, Spain
    • Active, not recruiting
    • Hospital Vall d'Hebron
  • Castelló, Spain
    • Active, not recruiting
    • Consorcio Hospitalario Provincial de Castellon
  • Córdoba, Spain
    • Active, not recruiting
    • Hospital Universitario Reina Sofia
  • Granollers, Spain
    • Recruiting
    • Hospital de Granollers
    • Contact: Fátima del Molino Sanz, MD
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Carmen Díaz Pedroche, MD
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Alicia Lorenzo Hernández, MD
  • Madrid, Spain
    • Active, not recruiting
    • Hospital Universitario Infanta Sofía
  • Madrid, Spain
    • Active, not recruiting
    • Clinica Universidad de Navarra
  • Murcia, Spain
    • Recruiting
    • Hospital Universitario Virgen de la Arrixaca
    • Contact: Vladimir Salazar Rosa, MD
  • Pamplona, Spain
    • Active, not recruiting
    • Clinica Universidad de Navarra
  • Sevilla, Spain
    • Active, not recruiting
    • Hospital Universitario de Valme
  • Valencia, Spain
    • Active, not recruiting
    • Hospital Universitari i Politecnic La Fe
  • Barcelona
    • Badalona, Barcelona, Spain
      • Recruiting
      • Hospital Germans Trias i Pujol
      • Contact: Juan José López Núñez, MD
    • Santa Coloma De Gramenet, Barcelona, Spain
      • Recruiting
      • Fundacio Hospital de L'Esperit Sant
      • Contact: Gloria de la Red Bellvis, MD
  • Seville
    • Sevilla, Seville, Spain, 41013
      • Recruiting
      • Hospital Universitario Virgen Del Rocio
      • Contact: Luis Jara-Palomares, MD; Phone Number: 0034667956480; Email: luisoneumo@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: Extended screening; Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).	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.; Other Names: 18-Fludeoxyglucose (18FDG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Principal Investigator: Luis Jara Palomares, MD/PhD, Hospitales Universitarios Virgen del Rocío

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Screening; Pulmonary Embolism; Venous Thromboembolic Disease; Occult Cancer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Pulmonary Embolism; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: SOME RIETE; 2018-003958-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD to be shared with the center participants once the study is officially finished in the foreseen period of three years.
• IPD Sharing Time Frame: 3 years time
• IPD Sharing 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 Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No