Screening for Cancer in Patients With Thromboembolic Disease (PEETAC)
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|ClinicalTrials.gov Identifier: NCT03937583|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolic Disease Respiratory Disease Pulmonary Disease Deep Venous Thrombosis Pulmonary Embolism||Drug: Fludeoxyglucose 18F||Phase 2|
Venous thromboembolic disease (VTD) is an entity constituted by deep vein thrombosis (DVT) and by pulmonary embolism (PE) produced as a result of the migration of a thrombus from the venous territory, usually originated in the lower limbs, to the tree pulmonary artery. VTE is a complex disease with a multifactorial cause, influenced by the patient's history, clinical risk factors, and genetic and environmental interactions.
There is a clearly established relationship between VTD and the presence of an underlying cancer. In addition, ETV can be the first manifestation of cancer in some patients.
Therefore, the objective of this clinical trial is to perform screening with 18DFG PET-CT in patients with unprovoked high-risk VTD to evaluate if it is possible to diagnose a great number of not diagnosed neoplasms at an earlier stage and to evaluate which impact would have on survival and the quality of life.
For all this, we propose this clinical trial in which we will compare a limited screening strategy (usual management of patients with unprovoked VTE) versus extended screening (through 18FDG PET-CT), in patients at high risk of developing cancer in the follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Screening for Cancer With PET /TC Scan in Patients With Unprovoked Venous Thromboembolic Disease With High Risk of Developing Cancer. (PEETAC)|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
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.
- Number of neoplasms diagnosed using extended screening [ Time Frame: 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.
- Number of neoplasms diagnosed in early phase using extended screening [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937583
|Contact: Luis Jara Palomares, MD/PhD||+34 firstname.lastname@example.org|
|Contact: Clara M Rosso Fernández, MD/PhDemail@example.com|
|Principal Investigator:||Luis Jara Palomares, MD/PhD||Hospitales Universitarios Virgen del Rocío|