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Venous Thromboembolic DiseasePhase 4SOME-RIETENCT03937583

Screening for Cancer in Patients With Unprovoked VTE

A Phase 4 study testing Fludeoxyglucose 18F in people with Venous Thromboembolic Disease and Respiratory Disease, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 17 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fludeoxyglucose 18F
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
17 sitesSpain
Study dates
23 Oct 2019to 31 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

17 sites in 1 country.

Luis Jara Palomares, MD/PhD contact

+34 955012144

luisoneumo@hotmail.com

Clara M Rosso Fernández, MD/PhD contact

+34955012144

claram.rosso.sspa@juntadeandalucia.es

17 sites in 1 country

Spain17 sites, 9 recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona

    Juan José López Núñez, MD

    Recruiting

  • Hospital Clínic de Barcelona

    Barcelona

    Jesús Aibar Gallizo, MD

    Recruiting

  • Hospital del Mar

    Barcelona

    Marina Suarez Pinera, MD

    Diego Agustin Rodríguez, MD

    Recruiting

  • Hospital Vall d'Hebrón

    Barcelona

    Active, not recruiting

  • Consorcio Hospitalario Provincial de Castellón

    Castelló

    Active, not recruiting

  • Hospital Universitario Reina Sofía

    Córdoba

    Active, not recruiting

  • Hospital de Granollers

    Granollers

    Fátima del Molino Sanz, MD

    Recruiting

  • Clínica Universidad de Navarra

    Madrid

    Active, not recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Carmen Díaz Pedroche, MD

    Recruiting

  • Hospital Universitario Infanta Sofía

    Madrid

    Active, not recruiting

  • Hospital Universitario La Paz

    Madrid

    Alicia Lorenzo Hernández, MD

    Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    Murcia

    Vladimir Salazar Rosa, MD

    Recruiting

  • Clínica Universidad de Navarra

    Pamplona

    Active, not recruiting

  • Fundació Hospital de L'Esperit Sant

    Santa Coloma de Gramenet, Barcelona

    Gloria de la Red Bellvis, MD

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, Seville, 41013

    Luis Jara-Palomares, MD, 0034667956480, luisoneumo@hotmail.com

    Recruiting

  • Hospital Universitario de Valme

    Seville

    Active, not recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia

    Active, not recruiting

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Being tested
Fludeoxyglucose 18F
Keywords
Venous Thromboembolic Disease, Pulmonary Embolism, Screening, Occult Cancer
Medical subject headings
Respiration Disorders, Lung Diseases, Venous Thrombosis, Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fludeoxyglucose 18FDrug

    Also called 18-Fludeoxyglucose (18FDG)

    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.

Study groups in NCT03937583
Study groupRoleWhat they receive
Limited screeningNo interventionComplete clinical history, along with routine physical, analytical examination (creatinine, sodium, potassium, red series, white series, liver and calcium profile) and chest x-ray.
Extended screeningExperimentalLimited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).
Receives: Drug: Fludeoxyglucose 18F

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After 3 years of follow-up

Secondary outcomes (3)

  1. 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.

    Measured: After 3 years of follow-up

  2. 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.

    Measured: Until the patient death or finalization of study after three years of follow-up

  3. 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.

    Measured: Baseline and after 90, 180 and 365 days of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start23 Oct 2019
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03937583
Sponsor's protocol ID
SOME RIETE
Other IDs
2018-003958-25, 2018
Acronym
SOME-RIETE
Status last verified
Nov 2021
First submitted
30 Apr 2019
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD to be shared with the center participants once the study is officially finished in the foreseen period of three years.

Publications

  • Barca-Hernando M, Otalora-Valderrama S, Lopez-Nunez JJ, Portillo-Sanchez J, Pagan-Escribano J, Lopez-Miguel P, Mahe I, Mena-Munoz E, Jou-Segovia I, Imbalzano E, Agudo-de Blas P, Lorenzo-Hernandez A, Diaz-Pedroche C, Aibar-Gallizo J, de la Red-Bellvis G, Del Molino-Sanz F, Amado-Fernandez C, Fernandez-Reyes JL, Villalobos-Sanchez A, Lopez-Saez JB, Diaz-Brasero AM, Marcos-Jubilar M, Meireles J, Marchena-Yglesias PJ, Diaz-Peromingo JA, Marin-Romero S, Elias-Hernandez T, Andrade-Ruiz HA, Mehdipour G, Bikdeli B, Jara-Palomares L; SOME-RIETE and ValRIETEs Investigators. Occult cancer in patients with unprovoked venous thromboembolism: Rationale, design, and methods of the VaLRIETEs study and the SOME-RIETE trial. Am Heart J. 2025 Jun;284:81-93. doi: 10.1016/j.ahj.2025.02.004. Epub 2025 Feb 17.

    PubMed 39971173

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fludeoxyglucose 18F in people with Venous Thromboembolic Disease and Respiratory Disease, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 17 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luis Jara Palomares, MD/PhD (+34 955012144, luisoneumo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of neoplasms diagnosed using extended screening (time frame: After 3 years of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

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