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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
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Brief Summary:

Study Rational

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.

Methodology

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.

Trial objectives

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

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
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)
Primary Purpose: Screening
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

Arm Intervention/treatment
No Intervention: Control cohort
Experimental: Infected cohort Diagnostic Test: Peripheral venous ultrasound
Screening for VTE from D7 to 42




Primary Outcome Measures :
  1. Rate of venous thromboembolism [ Time Frame: From Day 9 to Day 42 ]
    Deep venous thrombosis and/or pulmonary embolism.


Secondary Outcome Measures :
  1. Hospitalization due to venous thromboembolism [ Time Frame: Day 23 ]
    Rate of hospitalization

  2. Overall Survival [ Time Frame: Day 23 ]
    Time between the date of inclusion and the date of death for any reason.

  3. Specific survival [ Time Frame: Day 23 ]
    Time between the date of inclusion and the date of death for venous thromboembolism.

  4. 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

  5. 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)

  6. 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)

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 testing ;
  • Age ≥ 18 years old ;
  • Patient treated for histologically proven cancer (under treatment or last anti-neoplastic treatment < 3 months at the time of COVID-19 testing);
  • For the infected cohort: patient being screened for VTE at least one time 7 weeks after the COVID-19 diagnosistwo time point (day 1-10 after COVID-19 testing, and day 20-25 after COVID-19 testing) for retrospective cohort only;
  • Complete blood count available at time of COVID-19 testing (+/-14 days) to be able to calculate the Khorana score;
  • Patient informed and not opposed to the data processing;
  • Patient affiliated with a health insurance system.

Exclusion Criteria:

  • Patient not able to give free consent;
  • Patient not able to understand the protocol;
  • For the infected patients: VTE screening not performed (for retrospective cohort only);
  • No available complete blood count at time of COVID-19 testing; Medical file and clinical follow-up not available during the study period (76 weeks after the COVID-19 test);
  • Patients under 18 years;
  • Vulnerable persons as defined by article L1121-5-8:

    1. Pregnant women, women in labour or breast-feeding mothers, persons deprived of their freedom by judicial or administrative decision, persons hospitalized without their consent by virtue of articles L. 3212-1 and L. 3213-1 and who are not subject to the provisions of article L. 1121-8
    2. Persons admitted to a social or health facility for reasons other than research
    3. Adults subject to a legal protection order or unable to give their consent

Information from the National Library of Medicine

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


Contacts
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Contact: Céline CELLIER-COËLLE 0492031778 celine.coelle@nice.unicancer.fr

Locations
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France
Clinique Saint-Jean Recruiting
Cagnes-sur-Mer, Alpes-Maritimes, France, 06800
Contact: Jérome BARRIERE, MD-PHD    04.92.03.11.12    docteurbarriere@outlook.fr   
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    dr.hoch@gmail.com   
Sub-Investigator: Benjamin HOCH, MD-PHD         
CHU Nice Recruiting
Nice, Alpes-Maritimes, France, 06000
Contact: Denis DOYEN, MD-PHD       doyen.d@chu-nice.fr   
Sub-Investigator: Denis DOYEN, MD-PHD         
Clinique Saint-Georges Recruiting
Nice, Alpes-Maritimes, France, 06105
Contact: Ophélie CASSUTO, MD-PHD    04.92.03.10.29    ophelie.cassuto@nice.unicancer.fr   
Sub-Investigator: Ophélie CASSUTO, MD-PHD         
Centre Antoine Lacassagne Recruiting
Nice, Alpes-Maritimes, France, 06189
Contact: Céline CELLIER-COËLLE    0492031778    celine.coelle@nice.unicancer.fr   
Principal Investigator: Jérôme DOYEN, MD-PHD         
Monaco
CHPG Recruiting
Monaco, Monaco, 98000
Contact: Christophe PERRIN, MD-PHD    377.97.98.36.95    christophe.perrin@chpg.mc   
Sub-Investigator: Christophe PERRIN, MD-PHD         
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
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Principal Investigator: Jérôme DOYEN, MD-PHD Centre Antoine Lacassagne
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Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT04616846    
Other Study ID Numbers: 2020/20
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Antoine Lacassagne:
cancer
Covid19
Thromboembolism
Additional relevant MeSH terms:
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Neoplasms
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases