Clinical Trials Logo
  1. Home
  2. Lung Cancer
  3. NCT04407143
  4. Details
NCT04407143 Clinical Trial

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

Lung Cancer Clinical Trial

— SOLID  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04407143
Other study ID # GECP 20/04_SOLID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date May 30, 2022

Study information
Verified date June 2022
Source Fundación GECP
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 1980
Est. completion date May 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients diagnosed with lung cancer at any stage of the disease 2. Age = 18 3. Patients who have signed the informed consent for this study Exclusion Criteria: 1. Patients who have not signed or do not wish to sign the informed consent for this study

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• IgG test
IgG+ blood test by ELISA method.

Locations
Country Name City State
Spain Complejo Hospitalario de A Coruña A Coruña
Spain Hospital La Esperanza A Coruña
Spain Hospital Universitario de Ferrol A Coruña
Spain Hospital Virgen de los Lirios Alicante
Spain Hospital Germans Trias i Pujol Badalona
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Universitari Dexeus Barcelona
Spain Hospital Universitario Cruces Bilbao
Spain Hospital Universitario de Burgos Burgos
Spain Hospital Universitario San Pedro de Alcántara Cáceres
Spain Hospital Universitario Puerto Real Cadiz
Spain Hospital Universitario Puerta del Mar Cádiz
Spain Hospital General La Mancha Centro Ciudad Real
Spain Hospital Universitario Reina Sofía Córdoba
Spain Hospital General Universitario de Elche Elche Alicante
Spain Hospital Universitario de Vinalopó Elche
Spain Hospital Dr. Josep Trueta Girona
Spain Hospital Universitario de Guadalajara Guadalajara
Spain ICO Hospitalet Hospitalet de Llobregat Barcelona
Spain Complejo Hospitalario de Jaén Jaén
Spain Hospital Universitario Insular de Gran canaria Las Palmas De Gran Canaria Gran Canaria
Spain Complejo Asistencial Universitario de León León
Spain Hospital universitari Arnau de Vilanova Lleida
Spain Hospital San Pedro Logroño
Spain Hospital Universitario Lucus Augusti Lugo
Spain Clínica Universidad de Navarra Madrid
Spain Hospital de Sanchinarro Madrid
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Puerta de Hierro Madrid
Spain Hospital Severo Ochoa Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario de Móstoles Madrid
Spain Hospital Universitario del Henares Madrid
Spain Hospital Universitario Fundación Alcorcón Madrid
Spain Hospital Universitario Fundación Jiménez Díaz Madrid
Spain Hospital Universitario Infanta Cristina Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitario Infanta Sofía Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Príncipe de Asturias Madrid
Spain Hospital Costa del Sol Málaga
Spain Hospital General Universitario de Málaga Málaga
Spain Complejo Hospitalario Universitario de Ourense Santa María Nai Ourense
Spain Hospital Universitario Son Espases Palma De Mallorca
Spain Hospital Universitario Son Llàtzer Palma De Mallorca Mallorca
Spain Clínica Universidad de Navarra Pamplona
Spain Complejo Hospitalario de Navarra Pamplona
Spain Hospital Universitario Sant Joan de Reus Reus
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Universitario de Canarias Santa Cruz De Tenerife
Spain Hospital General de Segovia Segovia
Spain Hospital Virgen del Rocío Sevilla
Spain Hospital Sant Pau i Santa Tecla Tarragona
Spain Hospital Universitario Nuestra Señora de Candelaria Tenerife
Spain Hospital Universitario de Torrejón Torrejón Madrid
Spain Hospital Arnau de Vilanova Valencia
Spain Hospital Clínico Universitario de Valencia Valencia
Spain Hospital de Manises Valencia
Spain Hospital General de Valencia Valencia
Spain Hospital General Universitario de Valencia Valencia
Spain Hospital Lluís Alcanyís Valencia
Spain Hospital Universitari i Politécnic La Fe Valencia
Spain Hospital Universitario Dr. Peset Valencia
Spain Hospital Clínico Universitario de Valladolid Valladolid
Spain Hospital Universitario Río Ortega Valladolid
Spain Complexo Hospitalario Universitario de Vigo Vigo Pontevedra
Spain Complejo Hospitalario Zamora Zamora

Sponsors (1)
Lead Sponsor Collaborator
Fundación GECP

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Description of the characteristics of patients Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection. From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks
Secondary Detection of antibodies (IgG) at 6 months after SARS-COV2 vaccines 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. From the date of complete SARS-COV2 vaccination administration until 6 month
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk

External Links