Information about the study

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The ValRieteS study is an international, multicenter, prospective, cohort study, in patients with a first unprovoked symptomatic venous thromboembolic event. Patients will be follow up for 1 year to know if they are diagnosed by unknown cancer, for externally validating the RIETE score, developed for identifying patients with unprovoked VTE who are at an increased risk for occult cancer.

 

 

STUDY OUTCOMES

 

Primary outcome

• To validate, prospectively, the RIETE prognostic score for identifying which patients with VTE are at an increased risk for subsequent cancer.

Secondary outcomes

• Early-stage solid cancer according to risk stratification by RIETE score.
• All-cause mortality according to risk stratification by RIETE score.
• Cancer-related mortality according to risk stratification by RIETE score.
• Solid cancer and site of cancer according to risk stratification by RIETE score.
• Hematological cancer according to risk stratification by RIETE score.
• Analyze the value of D-dimer, at the time of the VTE event, as a predictor of cancer.

 

INCLUSION AND EXCLUSION CRITERIA

 

Inclusion criteria

1. First episode of objectively confirmed, symptomatic, unprovoked pulmonary embolism and/or distal or proximal deep vein thrombosis of the leg.
2. Age 18 years or older.
3. Written informed consent.

Exclusion criteria

1. Known malignant disease prior to VTE defined as a cancer diagnosis or cancer treatment within the past 5 years (of note: suspected but unconfirmed cancer at diagnosis of VTE is allowed).
2. Trauma or fracture of the leg, surgical procedures, general anaesthesia, or immobilization greater than 3 days within previous 3 months.
3. Previous unprovoked venous thromboembolism.
4. Known hereditary or acquired thrombophilia.
5. Current pregnancy or puerperium (up to 3 months postpartum).
6. Current estrogen therapy.
7. Greater than 30 days after VTE diagnosis;
8. Inability or refusal to provide written informed consent.

 

HOW TO PARTICIPATE

 

If you wish to participate in the study, please contact with the CRO: