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COMPLETED

G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2)

NCT01521338 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this research study is to collect blood and urine samples from people who have either the R117H type of CF or the non-G551D gating type of CF to be kept for future research.We will also use some of the collected blood to measure the number of neutrophils.

Conditions Studied

Study Locations (20)

Michigan

  • University of Michigan — Ann Arbor
  • Children's Hospital of Michigan — Detroit
  • Grand Rapids CF Center — Grand Rapids

Colorado

  • The Children's Hospital Colarado — Aurora
  • National Jewish Health — Denver

Indiana

  • Riley Hospital for Children Indiana University Medical Center — Indianapolis
  • Indianapolis University — Indianapolis

Massachusetts

  • Massachusetts General Hospital — Boston
  • Children's Hospital Boston — Boston

Alabama

  • University of Alabama at Birmingham — Birmingham

Arizona

  • Phoenix Childrens Hospital — Phoenix

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

California

  • Stanford University Medical Center — Palo Alto

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2014-01
Est. Completion 2021-06

Sponsor

Steven M Rowe

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01521338

The ClinicalTrials.gov registry entry for NCT01521338 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Steven M Rowe, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01521338 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Michigan, Colorado, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01521338 about?

NCT01521338 is a clinical study titled "G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2)". The goal of this research study is to collect blood and urine samples from people who have either the R117H type of CF or the non-G551D gating type of CF to be kept for future research.We will also use some of the collected blood to measure the number of neutrophils.

What is the current status of trial NCT01521338?

This trial is currently completed. The enrollment target is 120 participants. The study started on 2014-01. Estimated completion is 2021-06.

What conditions does trial NCT01521338 study?

This clinical trial studies the following conditions: Cystic Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT01521338?

This trial is sponsored by Steven M Rowe, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01521338 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial