CompletedNot Applicable

Cytomegalovirus-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients CMV-positive

Spain92 participantsStarted 2014-01

Plain-language summary

The purpose of this study is to determine the sensitivity and specificity of QuantiFeron® and ImmuKnow® in combination for early detection of patients who will develop CMV infection in lung transplant patients with CMV-positive serology (R+) prior to transplant.

Who can participate

Age range

18 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: * Patients aged ≥ 18 years. * Men or women who have received a lung transplant. * CMV-seropositive patients (R+). * Patients who have been informed of the study procedures and have signed the informed consent form. * Over 3 months posttransplant. Exclusion Criteria: * Patients who are not expected to be able to be followed during the first 12 months posttransplant. * Patient participation in another clinical trial or study will not be a criterion for exclusion.

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

Quantification of interferon-γ produced by specific CD8+ (cluster of differentiation 8) T cells after ex-vivo stimulation with various CMV epitopes using the commercial assay QuantiFeron®- CMV

Timeframe: up to 12 months from transplant

Measurement of overall immune response by determination of the activity of CD4+ (cluster of differentiation 4) T cells

Timeframe: up to 12 months from transplant

Quantification of CMV viral replication in blood measured by PCR (polymerase chain reaction)

Timeframe: up to 12 months from transplant

Trial details

NCT IDNCT02076971

SponsorFundacio Catalana de Pneumologia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-03

View on ClinicalTrials.gov More Cytomegalovirus Infections trials

Who can participate

Age range

18 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.

What they're measuring

Quantification of interferon-γ produced by specific CD8+ (cluster of differentiation 8) T cells after ex-vivo stimulation with various CMV epitopes using the commercial assay QuantiFeron®- CMV

Timeframe: up to 12 months from transplant

Measurement of overall immune response by determination of the activity of CD4+ (cluster of differentiation 4) T cells

Timeframe: up to 12 months from transplant

Quantification of CMV viral replication in blood measured by PCR (polymerase chain reaction)

Timeframe: up to 12 months from transplant