Clinical trial NCT03937583: Screening for Cancer in Patients With Unprovoked VTE
Official title: PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Venous Thromboembolic Disease
Respiratory Disease
Pulmonary Disease
Deep Venous Thrombosis
Pulmonary Embolism
Screening
Undefined
Keywords: Venous Thromboembolic Disease
Pulmonary Embolism
Screening
Occult Cancer
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of neoplasms diagnosed using extended screening
timeFrame: After 3 years of follow-up
Secondary outcomes:
measure: Number of neoplasms diagnosed in early phase using extended screening
timeFrame: After 3 years of follow-up
measure: Overall survival of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening
timeFrame: Until the patient death or finalization of study after three years of follow-up
measure: European Quality of Life-5 (EQ-5D scale validated in Spanish) of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening
timeFrame: Baseline and after 90, 180 and 365 days of follow-up
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: Fundació Hospital de L'Esperit Sant
state: Barcelona
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
state: Seville
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Castelló
country: Spain
facility: Consorcio Hospitalario Provincial de Castellón
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granollers
country: Spain
facility: Hospital de Granollers
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Luis Jara Palomares, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: