Diagnosis and Treatment of Patients With Cystic Fibrosis

February 2, 2026 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis.

Study Overview

Status

Terminated

Conditions

Detailed Description

This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis.

Study Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primarily local population but also any adult patient/relative that moves into the area, either through CF Foundation or relocating for personal reasons.

Description

  • INCLUSION CRITERIA
  • Patients with known or suspected CF and family members of patients with CF.
  • >=4 years of age

EXCLUSION CRITERIA

-Concomitant medical, psychiatric or other problems which might complicate interpretation of studies of CF, or for which we are unable to provide adequate care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CF Patients
cystic fibrosis patients
CF Relatives
relatives of cystic fibrosis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To develop a database and collection of samples obtained from patients with CF during their clinical care to allow for future research
Time Frame: end of study
To develop a collection of samples and a database from patients with cystic fibrosis to be used in future research.
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Christopher Koh, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1988

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimated)

November 4, 1999

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 870029
  • 87-DK-0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are open to sharing IPD if requested, but it has not as-to-date been requested from this protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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