Thromboembolic Risk Screening in Patients With Cancer and COVID-19 (NEOTHROCOVID)
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|ClinicalTrials.gov Identifier: NCT04616846|
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : November 5, 2020
Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. First data report high mortality in severe patients with 30% death rate at 28 days. Exact proportions of the reasons of death are unclear: severe respiratory distress syndrome is mainly reported which can be related to massive cell destruction by the virus, bacterial surinfection, cardiomyopathy or pulmonary embolism. The exact proportion of all these causes is unknown and venous thromboembolism could be a major cause because of the massive inflammation reported during COVID-19.
High levels of D-dimers and fibrin degradation products are associated with increased risk of mortality and some authors suggest a possible occurrence of venous thromboembolism (VTE) during COVID-19.
Indeed, COVID-19 infected patients are likely at increased risk of VTE. In a multicenter retrospective cohort study from China, elevated D-dimers levels (>1g/L) were strongly associated with in-hospital death, even after multivariable adjustment.
Also, interestingly,the prophylactic administration of anticoagulant treatment was associated with decreased mortality in a cohort of 449 patients, with a positive effect in patients with coagulopathy (sepsis-induced coagulopathy score ≥ 4) reducing the 28 days mortality rate (32.8% versus 52.4%, p=0.01).
However the presence/prevalence of VTE disease is unknown in COVID-19 cancer patients with either mild or severe disease. Cancer patients are at a higher risk of VTE than general population (x6 times) and could be consequently at a further higher of VTE during COVID-19, in comparison with non-cancer patients.
The exact rate of VTE and pulmonary embolism during COVID-19 was never evaluated, especially in cancer patients, and is of importance in order to understand if this disease needs appropriate prophylaxis against VTE.
The largest series of cancer patients so far included 28 COVID-19 infected cancer patients: the rate of mortality was 28.6%. 78.6% of them needed oxygen therapy, 35.7% of them mechanical ventilation. Pulmonary embolism was suspected in some patients but not investigated due to the severity of the disease and renal insufficiency, reflecting the lack of data in this situation.
The aim of the present study is to analyze the rate of symptomatic/occult VTE in a cohort of patients with cancer.
Expected benefits Anticipated benefits of the research are the detection of VTE in order to treat it for the included patient.
For all COVID-19 positive cancer patients it will enable to provide some guidelines and determine which patient are at risk for VTE and which will need ultrasound to detect occult VTE.
Foreseeable risks Foreseeable risks for patients are non-significant because the additional procedures needed are ultrasound exam, and blood sample test.
Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection.
Indeed, because the outbreak can end within the next 3-6 months, Investigators may not be able to answer the question if Investigators only focus on patients investigated prospectively. Investigators then decided to include patients from medical team who are already systemically screening patients with COVID-19 disease for VTE.
Main objective To evaluate the rate of venous thromboembolism at 23 days during COVID-19 infection in cancer patients.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Malignant Covid19 Thromboembolism||Diagnostic Test: Peripheral venous ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection.|
|Masking:||None (Open Label)|
|Official Title:||Thromboembolic Risk Screening in Patients With Cancer and COVID-19|
|Actual Study Start Date :||August 4, 2020|
|Estimated Primary Completion Date :||September 15, 2021|
|Estimated Study Completion Date :||September 15, 2021|
|No Intervention: Control cohort|
|Experimental: Infected cohort||
Diagnostic Test: Peripheral venous ultrasound
Screening for VTE from D7 to 42
- Rate of venous thromboembolism [ Time Frame: From Day 9 to Day 42 ]Deep venous thrombosis and/or pulmonary embolism.
- Hospitalization due to venous thromboembolism [ Time Frame: Day 23 ]Rate of hospitalization
- Overall Survival [ Time Frame: Day 23 ]Time between the date of inclusion and the date of death for any reason.
- Specific survival [ Time Frame: Day 23 ]Time between the date of inclusion and the date of death for venous thromboembolism.
- Safety profile using the common toxicity criteria from the NCI CTCAE V5.0 [ Time Frame: Day 1 to Day 23 ]Common toxicity criteria from the NCI CTCAE V5.0
- Predictive factors for venous thromboembolism [ Time Frame: Day 1 to Day 23 ]Khorana score (low risk (score=0), medium risk (score=1 ou 2) and high risk (score ≥ 3)
- Predictive factors for venous thromboembolism [ Time Frame: Day 1 to Day 23 ]Caprini score (very low risk (score=0), low risk (score=1 or 2), medium risk (score=3 or 4)and high risk (score ≥ 5)
- rate of symptomatic venous thromboembolism between the COVID-19 negative and COVID-19 positive patients [ Time Frame: Day 1 to Day 23 ]Common toxicity criteria from the NCI CTCAE V5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04616846
|Contact: Céline CELLIER-COËLLEemail@example.com|
|Cagnes-sur-Mer, Alpes-Maritimes, France, 06800|
|Contact: Jérome BARRIERE, MD-PHD 04.92.03.11.12 firstname.lastname@example.org|
|Sub-Investigator: Jérome BARRIERE, MD-PHD|
|Centre Azuréen de Cancérologie||Recruiting|
|Mougins, Alpes-Maritimes, France, 06250|
|Contact: Benjamin HOCH, MD-PHD 04.92.92.37.37 email@example.com|
|Sub-Investigator: Benjamin HOCH, MD-PHD|
|Nice, Alpes-Maritimes, France, 06000|
|Contact: Denis DOYEN, MD-PHD firstname.lastname@example.org|
|Sub-Investigator: Denis DOYEN, MD-PHD|
|Nice, Alpes-Maritimes, France, 06105|
|Contact: Ophélie CASSUTO, MD-PHD 04.92.03.10.29 email@example.com|
|Sub-Investigator: Ophélie CASSUTO, MD-PHD|
|Centre Antoine Lacassagne||Recruiting|
|Nice, Alpes-Maritimes, France, 06189|
|Contact: Céline CELLIER-COËLLE 0492031778 firstname.lastname@example.org|
|Principal Investigator: Jérôme DOYEN, MD-PHD|
|Monaco, Monaco, 98000|
|Contact: Christophe PERRIN, MD-PHD 3126.96.36.199.95 email@example.com|
|Sub-Investigator: Christophe PERRIN, MD-PHD|
|Principal Investigator:||Jérôme DOYEN, MD-PHD||Centre Antoine Lacassagne|