Study to Develop a Breath Analyser to Detect Chronic Kidn... | NCT03303222

Studies
Study to Develop a Breath Analyser to Detect Chronic Kidney Disease

NCT03303222

Sponsor

University College, London

Status

Unknown status

Last Update Posted

Nov 4, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Kidney Diseases

Interventions

breath

Countries

Not provided

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

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2021Estimated

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Nov 30, 2023Estimated

First Submitted Date

Oct 2, 2017

First Submission Date that Met QC Criteria

Oct 4, 2017

First Posted Date

Oct 5, 2017Actual

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

Nov 3, 2020

Last Update Posted Date

Nov 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Measure trimethylamine oxide in the breath.

Detailed Description

Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients with kidney disease, and volatile compounds such as TMAO can be detected in the breath.

The investigators wish to develop a breath analyser to measure volatile compounds, such as TMAO in the breath in patients with kidney disease.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients on dialysis		patients with kidney disease treated by dialysis	Diagnostic Test: breath
patients with chronic kidney disease		patients with chronic kidney disease not treated by dialysis	Diagnostic Test: breath

Interventions

Name	Type	Description	Arm Group Labels	Other Names
breath	Diagnostic Test	measurement of volatile compounds, such as TMAO in exhaled breath and blood	patients on dialysis patients with chronic kidney disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measurement of breath TMAO	measurement of breath TMAO by breath analyser	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with kidney disease under the care of Royal Free Hospital

Exclusion Criteria:

patients unable to provide informed consent
patients unable to exhale into breath analyser

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients with kidney disease under the care of Royal Free Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
andrew davenport, md	Contact	442077940500		andrewdavenport@nhs.net

Overall Officials

Name	Affiliation	Role
andrew davenport, md	UCL, London	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be filed in UCL library as PhD submission

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided