SOME-RIETE: Screening for Cancer in Patients With Unprovoked VTE

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)

Overall Status

Recruiting

CT.gov ID

NCT03937583

Collaborator

(none)

650

Enrollment

Locations

Arms

50.3

Anticipated Duration (Months)

38.2

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolic Disease Respiratory Disease Pulmonary Disease Deep Venous Thrombosis Pulmonary Embolism Screening Undefined	Drug: Fludeoxyglucose 18F	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

650 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 23, 2019

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Number of neoplasms diagnosed using extended screening [After 3 years of follow-up]
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.

Secondary Outcome Measures

Number of neoplasms diagnosed in early phase using extended screening [After 3 years of follow-up]
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.
Overall survival of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening [Until the patient death or finalization of study after three years of follow-up]
Estimate the impact of an active cancer search strategy using PET-CT in the overall survival in patients with high-risk unprovoked thromboembolic disease.
European Quality of Life-5 (EQ-5D scale validated in Spanish) of patients with high-risk unprovoked thromboembolic disease performing limited/extended screening [Baseline and after 90, 180 and 365 days of follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain
2	Fundació Hospital de L'Esperit Sant	Santa Coloma De Gramenet	Barcelona	Spain
3	Hospital Universitario Virgen del Rocío	Sevilla	Seville	Spain	41013
4	Hospital Clínic de Barcelona	Barcelona		Spain
5	Hospital del Mar	Barcelona		Spain
6	Hospital Vall d'Hebrón	Barcelona		Spain
7	Consorcio Hospitalario Provincial de Castellón	Castelló		Spain
8	Hospital Universitario Reina Sofía	Córdoba		Spain
9	Hospital de Granollers	Granollers		Spain
10	Clínica Universidad de Navarra	Madrid		Spain
11	Hospital Universitario 12 de Octubre	Madrid		Spain
12	Hospital Universitario Infanta Sofía	Madrid		Spain
13	Hospital Universitario La Paz	Madrid		Spain
14	Hospital Universitario Virgen de la Arrixaca	Murcia		Spain
15	Clínica Universidad de Navarra	Pamplona		Spain
16	Hospital Universitario de Valme	Sevilla		Spain
17	Hospital Universitari i Politècnic La Fe	Valencia		Spain