NCT06844344

Brief Summary

Lung cancer is the leading course of cancer related deaths world-wide. Lung cancer screening will increase the number of small lung lesion in need of biopsy to confirm the diagnosis. Obtaining lung biopsies with a bronchoscopy has the lowest risk of complications (1-2%) compared to other modalities such as transthoracic needle biopsy (20%), however diagnostic yield needs improvement. Currently a diagnosis is established in 50- 70% of the bronchoscopic procedures depending on the step-up. One way to improve the yield would be by using a cryo probe through the bronchoscope which freezes a small part of the lung for extraction, and thereby provides larger biopsies for examination. This will increase the chances of obtaining sufficient material from a small lesion to determine the diagnosis. The DR CRYO study will compare cryo biopsies to forceps biopsies for the diagnosis of peripheral lung lesions. We hope that the cryo biopsies can improve the diagnostic capabilities of bronchoscopy and provide better biopsies for tumor marker analyses. The project is relevant both for patients undergoing diagnostic work-up for lung cancer in early stages .

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
9mo left

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Study Progress62%
Mar 2025Feb 2027

First Submitted

Initial submission to the registry

January 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

January 23, 2025

Last Update Submit

February 19, 2025

Conditions

Lung CancerPeripheral Lung Lesions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    \- Total diagnostic yield, being defined as a tissue biopsy allowing a definite diagnosis of either a malignant or benign condition in the lung in proportion to the total number of procedures performed.

    One week after initial study procedure

Secondary Outcomes (7)

  • Malignant yield

    One year after initial study procedure

  • Benign yield

    One year after initial study procedure

  • NGS testing

    One week after initial study procedure

  • Complications

    One week after bronchoscopy

  • Serious procedure complications

    One week after bronchoscopy

  • +2 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

5 forceps biopsies followed by 5 cryo biopsies

Diagnostic Test: forceps biopsiesDiagnostic Test: Cryo biosies

Intervention

EXPERIMENTAL

5 Cryo biopsies follwed by 5 forcepsbiopsies

Diagnostic Test: forceps biopsiesDiagnostic Test: Cryo biosies

Interventions

forceps biopsiesDIAGNOSTIC_TEST

5 forceps biopsies

ControlIntervention
Cryo biosiesDIAGNOSTIC_TEST

5 cryo biopsies

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients undergoing diagnostic work-up for lung cancer due to a lung lesion surrounded by normal lung tissue (identified by CT)
  • Age 18 or above
  • Bronchoscopy with planned forceps sampling from the lesion

You may not qualify if:

  • \- Pregnancy
  • Not able to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Næstved Hospital

Næstved, Region Sjælland, 4700, Denmark

Location

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Amanda D Juul, MD, PhD

CONTACT

+4565412727amanda.dandanell.juul@rsyd.dk

Christian B Laursen, MD, Professor

CONTACT

christian.b.laursen@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: In this study we will compare the diagnostic yield of forceps biopsies to cryo biopsies. All patient will receive both cryo biopsies and forceps biopsies however the order of the biopsies will be randomized.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Senior researcher

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 25, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to patient confidentiality and the possibility to identify individual patients based on sensitive information.

Locations

DK(2)