NCT02759679

Brief Summary

The study aims to optimize and define a reproducible and non-invasive method for canine assisted lung cancer detection, using human breath samples from patients and controls for training and testing purposes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started May 2016

Typical duration for not_applicable lung-cancer

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

First Submitted

Initial submission to the registry

March 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

3.6 years

First QC Date

March 17, 2016

Last Update Submit

February 29, 2024

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity for lung cancer, of canines sniffing breath samples

    Patients and Controls deliver breath samples to be presented for dogs in a Remote facility. Outcomes will be reported for individual dogs and combinations of dogs.

    2 years

Study Arms (2)

Lung cancer

OTHER

Patients with lung cancer

Other: Human breath samples

Controls

OTHER

Controls being either healthy or having other lung disease

Other: Human breath samples

Interventions

Human breath samplesOTHER
ControlsLung cancer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers, lung cancer or other lung disease.

You may not qualify if:

  • Other known malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Øystein Fløtten, MD

    Haukeland University Hospital, Bergen, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2016

First Posted

May 3, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)