Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Infections

Symptoms and General Pathology

Lung Neoplasms

COVID-19

Communicable Diseases

Virus Diseases

Coronavirus Infections

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung cancer patients infected by COVID-19

IgG test

Mariano Provencio, MD

Observational, retrospective data collection and prospective IgG analysis, and multicenter study.

The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection.

For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.

Non-post-authorization study, retrospective of data collection and prospective of IgG analysis, observational and multicenter.

The study will be extended to all the sites of the Spanish Lung Cancer Group, more than 170 centers and 500 professionals, and it is expected that around 1,500 IgG tests will be carried out.

The study has three phases:

The scope of phase I is the identification of acquired immunity (IgG) in patients with lung cancer, whether or not they have presented symptoms of having suffered from COVID19. In addition, the description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection will be carried out.

For the identification of patients who contract COVID-19 infection, the IgG+ test in blood will be used by ELISA method.

The scope of phase II is the confirmation of the presence of antibodies (IgG) in patients who tested positive in Phase I of the study a few weeks after the first diagnosis made through the SOLID study.

The scope of phase III is the confirmation of the presence of antibodies (IgG) in patients with lung cancer who have been vaccinated with any of the available and authorized vaccines for SARS-COV2 and 6 months after said administration.

Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection

Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection

Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.

Confirmation of the presence of antibodies (IgG) in patients with lung cancer who have been vaccinated with any of the available and authorized vaccines for SARS-COV2 and 6 months after such administration.

Fundación GECP

Patients with stage I/II lung cancer will receive radical surgery.

No intervention

Zhenyi Niu

Hecheng Li, PhD, MD

The goal of this observational study is to learn about the effects of coronavirus infection in patients with early-stage lung cancer. The main question it aims to answer is whether the interval of surgery and COVID-19 infection will affect the surgery and prognosis of the patients.

Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer

Effects of Coronavirus Infection (COVID-19) on the Timing and Prognosis of Radical Surgery in Patients With Early-stage Lung Cancer

rate of perioperative complications, mainly include: pneumonia, respiratory failure, pulmonary embolism, arrhythmia, sepsis, cerebrovascular accident, myocardial injury, acute kidney injury.

Ruijin Hospital

Professor

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.

Coronavirus Disease 2019 (COVID-19), caused by a novel coronavirus (SARS-CoV-2), is a highly contagious disease that appeared in Wuhan, Hubei province of China in December 2019. It has now spread to multiple countries through infected persons travelling mainly by air. Most of the infected patients have mild symptoms including fever, fatigue and cough. But in severe cases, patients can progress rapidly and develop the acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulopathy including a disseminated intravascular coagulation (DIC).

Multiple myeloma (MM) is a mature B-cell malignancy largely affecting the older patient with a median age at presentation of 70 years. The general performance status (PS) and the presence of comorbidity can identify a group of patients with poor tolerance to treatment, as well as risks of both bacterial and viral infection. MM patients have benefited significantly from therapeutic developments, however, the host response biology of the older person, coupled with a distinct disease biology overlay induces immune dysfunction. For example, the impact of aging on the human immune system is well documented. In MM it has long-since been understood that there is a spectrum of immune dysregulation, an important host factor considered in the "Hallmarks of cancer" theory. In addition, the delivery of anti-MM therapy includes immune modulating agents such as steroids, proteasome inhibitors and CD38-directed therapy though not all immune modulation is necessarily detrimental.

As such, myeloma patients are considered a higher risk in the current pandemic with SARS-COVID19. However, it is not clear whether this is actually the case, and the risk may not be different to population in general. Equally it may be sub-groups of patients who are at risk e.g. on treatment versus stable response (plateau), frailty. AS such, this proposal aims to collect in an observational study, the outcomes of COVID19 infection in MM patients across Europe.

COVID-19 Infection and Multiple Myeloma

COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY

Costs related to Covid in terms of health resource needs.

Number of infection recovery for each systemic anti-cancer subgroup.

Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.

Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.

Number of frail patients with COVID-19 infection and resolution of it.

Number of infection and outcome per country.

Fondazione EMN Italy Onlus

Stichting European Myeloma Network

Acute Graft Versus Host Disease

Baseline and Day 28: Respiratory and Whole blood Samples Collected, Days 7 and 14: Respiratory Samples Collected

Monthly follow-up until Covid-19 is negative: Respiratory and Whole Blood Samples Collected

Baseline and Day 28: Respiratory and Whole blood Samples Collected, Days 7 and 14: Respiratory Samples Collected

Diego Hijano, MD

Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19.

Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future.

Primary Objective

* To determine the clinical characteristics and outcomes of Covid-19 in children.
* To characterize the clinical risk factors of Covid-19 in children..

Secondary Objectives

* To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children.
* To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

Nasal swabs will be collected from positive patient participants on Day 0. Timing of follow-up swabs will be guided by standard of care procedures.

Whole blood will be collected at Days 0. Follow-up blood sampling will be guided by standard of care procedures. Samples will be stored at -80oC.

Nasal swabs and whole blood will only be obtained at the same time standard of care procedures are performed. If a patient is not getting a blood draw, no sample will be collected.

Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children

Clinical characteristics, including demographics, underlying diagnosis, and signs/symptoms, and outcomes, such as hospitalization, oxygen requirements, and mortality, will be summarized with counts and percentages.

Pearson or Spearman's correlation of clinical risk factors such as age, underlying diagnosis, immunosuppression with outcomes as detailed in primary objective 1 will be evaluated.

Immunological (Absolute lymphocyte/monocyte counts (mm3) response measures, will be summarized with mean, standard deviation, median and range.

Immunological (Immunoglobulin level (mg/dL)) response measures, will be summarized with mean, standard deviation, median and range

The duration of viral shedding, defined as the time between the first positive test date and the first negative test date, will be summarized for all participants with mean, standard deviation, median and range.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection	NCT04407143	Lung Cancer COVID Corona Virus In...	IgG test	18 Years -	Fundación GECP
Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer	NCT05684549	Surgery Corona Virus In...	No intervention	18 Years -	Ruijin Hospital
COVID-19 Infection and Multiple Myeloma	NCT04492371	Multiple Myelom... Covid19 Corona Virus In...		18 Years - 99 Years	Stichting European Myeloma Network
Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer	NCT05684549	Surgery Corona Virus In...	No intervention	18 Years -	Ruijin Hospital
Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children	NCT04371315	Corona Virus In... Pediatric Cance... Adult Children Cancer		- 24 Years	St. Jude Children's Research Hospital
Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children	NCT04371315	Corona Virus In... Pediatric Cance... Adult Children Cancer		- 24 Years	St. Jude Children's Research Hospital
COVID-19 Infection and Multiple Myeloma	NCT04492371	Multiple Myelom... Covid19 Corona Virus In...		18 Years - 99 Years	Stichting European Myeloma Network
Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection	NCT04407143	Lung Cancer COVID Corona Virus In...	IgG test	18 Years -	Fundación GECP

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