## Protocol Section
### Identification Module
**NCT ID:** NCT02759679

**Brief Title:** Canine-Assisted Profiling of Lung Cancer From Human Breath

**Official Title:** Canine-Assisted Profiling of Lung Cancer From Human Breath

#### Organization Study ID Info
**ID:** REK_2013/2053
#### Organization
**Class:** OTHER
**Full Name:** Haukeland University Hospital
### Status Module
#### Completion Date
**Date:** 2019-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-01

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-29

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2019-12

**Type:** ACTUAL

#### Start Date
**Date:** 2016-05

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2016-05-03
**Type:** ESTIMATED
**Study First Submit Date:** 2016-03-17
**Study First Submit QC Date:** 2016-04-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Haukeland University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Lung Cancer

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 650

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with lung cancer

**Intervention Names:**

- Other: Human breath samples

**Label:** Lung cancer

**Type:** OTHER

#### Arm Group 2

**Description:** Controls being either healthy or having other lung disease

**Intervention Names:**

- Other: Human breath samples

**Label:** Controls

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Controls

- Lung cancer

**Name:** Human breath samples

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Sensitivity and specificity for lung cancer, of canines sniffing breath samples

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

Healthy volunteers, lung cancer or other lung disease.

Exclusion criteria:

Other known malignancy.

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bergen

**Country:** Norway

**Facility:** Haukeland University Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Haukeland University Hospital, Bergen, Norway

**Name:** Øystein Fløtten, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
