Diagnosis and Treatment of Patients With Cystic Fibrosis | NCT00001223

Studies
Diagnosis and Treatment of Patients With Cystic Fibrosis

NCT00001223

Sponsor

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

Status

Terminated

Last Update Posted

Feb 4, 2026Actual

Enrollment

79Actual

Phase

Not provided

Conditions

Cystic Fibrosis
Liver Disease or Abnormalities
Diabetes
Pancreatic Insufficiency (Exocrine and Endocrine)

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
87-DK-0029

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left NIH

Expanded Access Info

Start Date

Jan 1, 1988Actual

Primary Completion Date

Jan 30, 2026Actual

Completion Date

Jan 30, 2026Actual

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Nov 3, 1999

First Posted Date

Nov 4, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CF Patients		cystic fibrosis patients
CF Relatives		relatives of cystic fibrosis patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Koh, M.D.	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center		Bethesda	Maryland	20892	United States

Label	URL
NIH Clinical Center Detailed Web Page	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D008107	Liver Diseases
D000013	Congenital Abnormalities
D003920	Diabetes Mellitus
D010188	Exocrine Pancreatic Insufficiency
D001987	Bronchiectasis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided