Cystic FibrosisNCT00001223
Diagnosis and Treatment of Patients With Cystic Fibrosis
An observational study of Cystic Fibrosis and Liver Disease or Abnormalities, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 120 years
- Conditions the study is for
- Cystic Fibrosis, Liver Disease or Abnormalities, Diabetes
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 1988to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with known or suspected CF and family members of patients with CF.
- >=4 years of age
Who cannot join
- -Concomitant medical, psychiatric or other problems which might complicate interpretation of studies of CF, or for which we are unable to provide adequate care.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Liver Disease or Abnormalities, Diabetes, Pancreatic Insufficiency (Exocrine and Endocrine)
- Keywords
- Cystic Fibrosis, Pancreatic Insufficiency, Bronchiectasis, Liver Disease, Natural History
- Medical subject headings
- Cystic Fibrosis, Liver Diseases, Congenital Abnormalities, Diabetes Mellitus, Exocrine Pancreatic Insufficiency, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CF Patients | cystic fibrosis patients | |
| CF Relatives | relatives of cystic fibrosis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start1 Jan 1988
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Why it stopped: PI left NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christopher Koh, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001223
- Sponsor's protocol ID
- 870029
- Other IDs
- 87-DK-0029
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 1999
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are open to sharing IPD if requested, but it has not as-to-date been requested from this protocol.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00001223
- Acronym / sponsor ID
- 870029
- Conditions
- Cystic Fibrosis, Liver Disease or Abnormalities, Diabetes, Pancreatic Insufficiency (Exocrine and Endocrine)
- Keywords
- Cystic Fibrosis, Pancreatic Insufficiency, Bronchiectasis, Liver Disease, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left NIH
- Enrolment
- 79 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 1 Jan 1988 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF Patients | – | –cystic fibrosis patients |
| CF Relatives | – | –relatives of cystic fibrosis patients |
Who may qualify
- Ages
- 4 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with known or suspected CF and family members of patients with CF.
- >=4 years of age
Key exclusion criteria (1 listed)
- -Concomitant medical, psychiatric or other problems which might complicate interpretation of studies of CF, or for which we are unable to provide adequate care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: PI left NIH). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We are open to sharing IPD if requested, but it has not as-to-date been requested from this protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Koh, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Liver Disease or Abnormalities, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left NIH). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.