CLAD Phenotype Specific Risk Factors and Mechanisms (NCT02631720) | Clinical Trial Compass
CompletedNot Applicable
CLAD Phenotype Specific Risk Factors and Mechanisms
United States, Canada884 participantsStarted 2015-12-22
Plain-language summary
While many patients experience benefits from transplant, complications such as infections and lung rejection may affect long term survival and quality of life. In this study doctors are looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought to be chronic rejection of the lung by the immune system and is the leading cause of death after lung transplantation.
The purpose of this study is to help doctors determine:
* why some people get CLAD and others do not
* how patients who get CLAD do after CLAD is diagnosed
* how CLAD may affect quality of life
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
. Subject must be able to understand and provide written informed consent and
Must be ≥18 years of age at the time of written informed consent.
. Anticipated listing for lung transplantation OR within 45 days of having received a single or bilateral cadaveric donor lung transplant.
. Undergoing first lung transplant operation.
. Transplant surgery to be performed or performed at enrolling center.
Exclusion criteria
. Multi-organ recipient.
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
1
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
Timeframe: 90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
Trial details
NCT IDNCT02631720
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)