Rare Disease Trial, Recruiting NCT02461615 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: Rare Disease
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Rare Disease Trial, Recruiting

NCT02461615
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For Part A (a one-time study of PAP syndrome):

  • People who have signed a consent form (and an additional assent form, if required)
  • People who have had a chest CT scan or chest X-ray showing results that match a condition called PAP (pulmonary alveolar proteinosis)
  • People who have been diagnosed with PAP through at least one of the following: an abnormal blood test for GM-CSF antibodies; a lung biopsy confirming PAP; a lung wash (fluid sampling) procedure showing results consistent with PAP; or genetic testing showing specific gene mutations known to cause PAP

For Part B (an ongoing study with surveys, for autoimmune PAP patients only):

  • People who have signed a consent form (and an additional assent form, if required)
  • People who have been diagnosed with the autoimmune form of PAP, shown by an abnormal GM-CSF antibody blood test, AND at least one of the following: a chest CT or X-ray compatible with PAP; a lung biopsy confirming PAP; or a lung wash procedure showing results consistent with PAP

Who may not be able to join:

  • People who have a serious medical illness that the trial doctors believe would make it difficult for them to complete the study
  • People who do not have a confirmed diagnosis of PAP (for Part A)
  • People who do not have a confirmed diagnosis of the autoimmune form of PAP specifically (for Part B)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Bruce C Trapnell, MD, Children's Hospital Medical Center, Cincinnati

Phone: 513-636-8916

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 April 2015
Est. completion
1 December 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

DBS card GM-CSF autoantibody levels to diagnose Autoimmune PAP

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov