Thromboembolic Risk Screening in Patients With Cancer and COVID-19

NCT04616846 | Completed DMC

• 1 other identifier: 2020/20
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 6

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.

Conditions

Neoplasms Malignant; Covid19; Thromboembolism

Keywords

cancer; Covid19; Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Rate of venous thromboembolism

  Deep venous thrombosis and/or pulmonary embolism.

  From Day 9 to Day 42

Secondary Outcomes (7)

• Hospitalization due to venous thromboembolism

  Day 23

• Overall Survival

  Day 23

• Specific survival

  Day 23

• Safety profile using the common toxicity criteria from the NCI CTCAE V5.0

  Day 1 to Day 23

• Predictive factors for venous thromboembolism

  Day 1 to Day 23

Study Arms (2)

Control cohort

NO INTERVENTION

Infected cohort

EXPERIMENTAL

Diagnostic Test: Peripheral venous ultrasound

Interventions

Peripheral venous ultrasound DIAGNOSTIC_TEST

Screening for VTE from D7 to 42

Infected cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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
• Persons admitted to a social or health facility for reasons other than research
• Adults subject to a legal protection order or unable to give their consent

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (6)

Clinique Saint-Jean

Cagnes-sur-Mer, Alpes-Maritimes, 06800, France

Location

Centre Azuréen de Cancérologie

Mougins, Alpes-Maritimes, 06250, France

Location

CHU Nice

Nice, Alpes-Maritimes, 06000, France

Location

Clinique Saint-Georges

Nice, Alpes-Maritimes, 06105, France

Location

Centre Antoine Lacassagne

Nice, Alpes-Maritimes, 06189, France

Location

CHPG

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Neoplasms; COVID-19; Thromboembolism

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jérôme DOYEN, MD-PHD

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: August 4, 2020
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); MO (1)