AzTrials
AzTrials

Lung CancerNCT05804786

Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

An observational study of Lung Cancer, run by Seoul National University Bundang Hospital at 11 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary objective is To evaluate the usefulness and safety of advanced guided bronchoscopy for histological diagnosis of peripheral pulmonary lesions. The Secondary objective is to establish a strategy that can most effectively use endoscopes for early diagnosis of lung cancer in a real-world care environment by… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Guided bronchoscopy
Type of treatment
Medical device
How many people
1,240 participants
Where
11 sitesSouth Korea
Study dates
1 Apr 2023to 31 Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with peripheral pulmonary lesions that require histological differentiation because of the possibility of malignancy and are scheduled for biopsy attempted through guided bronchoscopy

Who may be able to join

  • Patients who agreed in writing to participate in this study
  • Adult men and women over 19 years of age
  • Patients who visited the hospital with lung lesions suspected of lung cancer and require a diagnostic biopsy
  • Patients capable of biopsy through guided bronchoscopy

Who cannot join

  • 1) Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yeon Wook Kim, MD., PhD contact

+82-31-787-8134

kimyw@snu.ac.kr

11 sites in 1 country

South Korea11 sites, 11 recruiting

  • Dongsan Hospital Keimyung University School of Medicine

    Daegu

    Sun Hyo Park

    Recruiting

  • Hallym University Dongtan Sacred Heart Hospital

    Gyeonggi-do

    So Jeong Kim

    Recruiting

  • Chunnam National University Hwasun Hospital

    Hwasun

    Hyung Joo Oh

    Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan

    Hyung Gu Kang

    Recruiting

  • Gyeongsang National University Hospital

    Jinju

    Jong Whan Jeong

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Yeon Wook Kim, MD, PhD, +82-31-787-8134, kimyw@snu.ac.kr

    Recruiting

  • Asan Medical Center, University of Ulsan College of Medicine

    Seoul

    Wonjun Ji

    Recruiting

  • Gangnam Severence Hospital

    Seoul

    Chi Young Kim

    Recruiting

  • Hanyang University Hostpital

    Seoul

    Dong Won Park

    Recruiting

  • The Catholic University of Korea, Seoul, Korea

    Seoul

    Hyeong Jun Cho

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan

    Seong Hoon Yoon

    Recruiting

Other trials in South Korea

About this study

Official title: Korean Multicenter Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

The primary objective is To evaluate the usefulness and safety of advanced guided bronchoscopy for histological diagnosis of peripheral pulmonary lesions.

The Secondary objective is to establish a strategy that can most effectively use endoscopes for early diagnosis of lung cancer in a real-world care environment by identifying patient/clinical/image/procedure-related characteristics that can optimize the practicality of emerging technologies.

Read the detailed description
  • Patients with peripheral pulmonary lesions who need histological diagnosis due to suspected lung cancer and whose lesions are judged capable of histological examination through guided bronchoscopy will be prospectively recruited.
  • This study is a pure non-interventional pragmatic design. In addition to biopsy for lung lesions using bronchoscopy, lung cancer staging and tests necessary for metastases and treatment for diagnosed lung cancer are performed according to existing guidelines and the judgment of medical staff.
  • We will analyze the clinical characteristics of guided bronchoscopy procedures used in clinical practice and the main results during the follow-up period of up to one year (diagnostic yield, sensitivity, safety, practicality, and various factors affecting usefulness).
Conditions
Lung Cancer
Being tested
Guided bronchoscopy
Keywords
Electromagnetic Navigation Bronchoscopy, Guided Bronchoscopy, Diagnosis, Radial Endobronchial Ultrasound
Medical subject headings
Lung Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guided bronchoscopyDevice

    Also called Device: Spin Thoracic Navigation System, Device: Radial EBUS probe

    It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.

Study groups in NCT05804786
Study groupRoleWhat they receive
single groupPatients with peripheral pulmonary lesions which require histological differentiation because of the possibility of malignancy, and a biopsy can be attempted through guided bronchoscopy
Receives: Device: Guided bronchoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic yield at index

    The proportion of pathologic results that leads to a specific malignant or benign

    Measured: Upon reports of pathologic results (up to 2 weeks after bronchoscopy)

Secondary outcomes (3)

  1. Diagnostic accuracy at 12 months

    True positive + True negative (confirmed benign with follow-up of at least 1yr without progression) / Total procedures

    Pathologic results of a malignant or benign specific diagnosis based on the samples collected via index ENB procedure are categorized as true positives or true negatives.

    For pathologic results of a benign non-specific diagnosis and non-diagnostic results, follow-up data would be used to determine whether the 12-month status corroborates the benign results. Based on definition scenarios, these results will be determined as true negatives or false negatives. Diagnostic yields based on different scenarios will be reported.

    Measured: Confirmed by follow-up results at 1 year

  2. Sensitivity for malignancy

    True positive/Confirmed malignancy cases

    Measured: Confirmed by follow-up results at 1 year

  3. Complication

    Evaluate complications due to guided bronchoscopic biopsy

    Measured: Confirmed by follow-up results at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start1 Apr 2023
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
1,240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05804786
Sponsor's protocol ID
K-ORIENT
Status last verified
May 2024
First submitted
27 Mar 2023
Last updated
10 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Folch EE, Pritchett MA, Nead MA, Bowling MR, Murgu SD, Krimsky WS, Murillo BA, LeMense GP, Minnich DJ, Bansal S, Ellis BQ, Mahajan AK, Gildea TR, Bechara RI, Sztejman E, Flandes J, Rickman OB, Benzaquen S, Hogarth DK, Linden PA, Wahidi MM, Mattingley JS, Hood KL, Lin H, Wolvers JJ, Khandhar SJ; NAVIGATE Study Investigators. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2019 Mar;14(3):445-458. doi: 10.1016/j.jtho.2018.11.013. Epub 2018 Nov 23.

    PubMed 30476574

  • Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.

    PubMed 26367186

  • Folch EE, Labarca G, Ospina-Delgado D, Kheir F, Majid A, Khandhar SJ, Mehta HJ, Jantz MA, Fernandez-Bussy S. Sensitivity and Safety of Electromagnetic Navigation Bronchoscopy for Lung Cancer Diagnosis: Systematic Review and Meta-analysis. Chest. 2020 Oct;158(4):1753-1769. doi: 10.1016/j.chest.2020.05.534. Epub 2020 May 23.

    PubMed 32450240

  • Vachani A, Maldonado F, Laxmanan B, Kalsekar I, Murgu S. The Impact of Alternative Approaches to Diagnostic Yield Calculation in Studies of Bronchoscopy. Chest. 2022 May;161(5):1426-1428. doi: 10.1016/j.chest.2021.08.074. Epub 2021 Sep 7. No abstract available.

    PubMed 34506792

  • Bowling MR, Kohan MW, Walker P, Efird J, Ben Or S. The effect of general anesthesia versus intravenous sedation on diagnostic yield and success in electromagnetic navigation bronchoscopy. J Bronchology Interv Pulmonol. 2015 Jan;22(1):5-13. doi: 10.1097/LBR.0000000000000120.

    PubMed 25590477

  • Kops SEP, Heus P, Korevaar DA, Damen JAA, Idema DL, Verhoeven RLJ, Annema JT, Hooft L, van der Heijden EHFM. Diagnostic yield and safety of navigation bronchoscopy: A systematic review and meta-analysis. Lung Cancer. 2023 Jun;180:107196. doi: 10.1016/j.lungcan.2023.107196. Epub 2023 Apr 19.

    PubMed 37130440

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Seoul National University Bundang Hospital at 11 sites in South Korea.

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 4 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: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yeon Wook Kim, MD., PhD (+82-31-787-8134, kimyw@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic yield at index (time frame: Upon reports of pathologic results (up to 2 weeks after bronchoscopy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05804786, which also lists 6 linked publications.

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 10 May 2024.

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