UnknownNot Applicable

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

Spain150 participantsStarted 2019-05-01

Plain-language 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)

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT03591978

SponsorUniversidad de Granada

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-11-01

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