Isolation of Circulating Pulmonary Cells in COPD and Its Relationship With Clinical Relevant Outcomes (IbICEnCa)

NCT03591978 | Unknown

• 1 other identifier: CPCEST001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

We have demonstrated for the very first time that it is possible to isolate CPCs (circulating pulmonary cells) in patients with COPD in a sample of 17 patients (with a recovery rate of nearly 40%) and none of 10 healthy, non- smokers controls with a patented method \[provisional Spanish Patent Application (P201730724)\], based on liquid biopsy methodology (Romero Palacios et at, submitted 2017), showing that patients with COPD and isolation of CPCs have a more severe disease (expressed as higher BODEx index) and a trend towards a higher rate of decline of lung function as well as an increased rate of exacerbations, suggesting that CPCs isolation could be of value as a diagnostic and prognostic tool identifying patients with more active diseases. However, due to the small sample, no definitive conclusions could be made. Moreover, as there were no healthy smokers included in this study, we couldn´t evaluate if CPCs could be isolated in this type of population. The fact that CPCs could be isolated in a group of patients with COPD and its relationship with greater severity suggests that this could be a marker of progression of the disease and could detect those patients more likely to benefit from newer antiinflamatory therapies(17)

Conditions

COPD; COPD Exacerbation; COPD, Severe Early-Onset

Keywords

Disease progression; Circulating Pulmonary Cells

Outcome Measures

Primary Outcomes (1)

• Evaluate the prevalence of CPCs isolation in peripheral blood from COPD patients, smoking and non-smoking healthy controls with a patented liquid-biopsy technique.

  1 year

Secondary Outcomes (6)

• Establish if there are differences between CPCs isolation rates from COPD patients, smoking and non-smoking healthy controls

  1 year

• Evaluate the relationship between CPCs isolation and the degree of parenchymal destruction and empyshema expresed as DLCO and kCO

  1 year

• Evaluate the relationship between CPCs isolation and emphysema degree expressed as CT scan measurements (% LAA).

  1 year

• Evaluate the relationship between historical FEV1decline and CPCs isolation in COPD patients.

  2 year

• Evaluate the relationship between prospective 1 year FEV1 decline and CPCs isolation in COPD patients.

  1 year

Other Outcomes (5)

• Evaluate the rate of moderate and severe exacerbations during 1-year follow up between COPD patients with and without CPCs isolation after adjustment for confounding variables

  1 year

• Evaluate the time to first moderate and severe exacerbation during 1-year follow up between COPD patients with and without CPCs isolation after adjustment for confounding variables.

  1 year

• Evaluate if there are differences in the rate of CPCs isolation between those patients with early onset COPD (defined as those with COPD before 60 years of age) and those with normal onset COPD (defined as those with COPD after 60 years of age).

  1 year

Study Arms (3)

Healthy non smokers

Healthy subjects with no respiratory disease and never smokers

Diagnostic Test: Isolation of Circulating Pulmonary Cells in peripheral blood

Healthy smokers

Healthy subjects without respiratory disease and at least a cumulative tobacco consumption history of \<10 pack-years

Diagnostic Test: Isolation of Circulating Pulmonary Cells in peripheral blood

COPD

COPD patients (diagnosed as recommended by GOLD 2017 strategy) former or current smokers with at least \>10 pack-years

Diagnostic Test: Isolation of Circulating Pulmonary Cells in peripheral blood

Interventions

Isolation of Circulating Pulmonary Cells in peripheral blood DIAGNOSTIC_TEST

Blood samples from healthy volunteers will be collected in EDTA tubes (Vacutainer, BD Bioscience). CPC will be isolated according to previous patented method (P201730724)

COPD; Healthy non smokers; Healthy smokers

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 healthy non-smokers, 30 healthy smokers and 100 patients with COPD (70 patients with mild to moderate disease- 35 of them below 60 years-old and 35 above 60 years-old-, and 30 patients with severe to very severe COPD -15 of them below 60 years-old and 15 above 60 years-old).

You may qualify if:

• Adults of \>35 years-old.
• Patients who have given written informed consent
• Absence of respiratory infection or COPD exacerbation in the 4 previous weeks to baseline visit.

You may not qualify if:

• Other respiratory condition apart from COPD, such as previous diagnosis of bronchial asthma, obstructive sleep apnoea, idiopathic pulmonary fibrosis, pulmonary tuberculosis, alpha1 antitrypsin deficiency.
• Current or previous cancer history (even if the patient has been diagnosed \>5 years and there is no evidence of recurrence of disease).
• Unwillingness to perform pulmonary function test or CT scan.
• Participation in another investigational study or clinical trial.

Sponsors & Collaborators

• Universidad de Granada: lead
• Hospital de Alta Resolucion de Loja. Agencia Sanitaria Hospital de Poniente: collaborator
• Junta de Andalucia: collaborator

Study Sites (4)

Hospital de Alta Resolución de Loja

Loja, Granada, 18300, Spain

RECRUITING

Hospital Universitario de Torrecardenas

Almería, Spain

RECRUITING

Universidad de Granada- Facultad de Medicina

Granada, 18002, Spain

NOT YET RECRUITING

GENYO, centro Pfizer- Universidad de Granada- Junta de Andalucía de inestigación genómica y oncológica

Granada, 18011, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Disease, Chronic Obstructive, Severe Early-Onset; Disease Progression

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Rector for Research and Transfer

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: May 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: May 1, 2021
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At the end of recruitment and analysis
• Access Criteria: Upon reasonable request

Locations

ES (4)