NCT00001223

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1988

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1988

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
26.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

38.1 years

First QC Date

November 3, 1999

Last Update Submit

February 2, 2026

Conditions

Keywords

Cystic FibrosisPancreatic InsufficiencyBronchiectasisLiver DiseaseNatural History

Outcome Measures

Primary Outcomes (1)

  • To develop a database and collection of samples obtained from patients with CF during their clinical care to allow for future research

    To develop a collection of samples and a database from patients with cystic fibrosis to be used in future research.

    end of study

Study Arms (2)

CF Patients

cystic fibrosis patients

CF Relatives

relatives of cystic fibrosis patients

Eligibility Criteria

Age4 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Cystic FibrosisLiver DiseasesCongenital AbnormalitiesDiabetes MellitusExocrine Pancreatic InsufficiencyBronchiectasis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBronchial Diseases

Study Officials

  • Christopher Koh, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

January 1, 1988

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations