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RecruitingNCT07488507Updated Mar 23, 2026

Diagnostic Value and Safety of Combined Biopsy for Mediastinal Metastasis of Lung Cancer

An interventional study of EBUS-TBMCB in Mediastinal Metastases of Lung Cancer, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Third Military Medical University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The study is aimed o evaluate the diagnostic performance and treatment guidance of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) combined with transbronchial mediastinal cryobiopsy (EBUS-TBMCB) in patients with mediastinal metastases of lung cancer.

Read the detailed description

A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), will serve as control. Enrolled patients will be randomly assigned to two groups: the experimental group, which will undergo EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) following EBUS-TBNA, and control group, which will undergo EBUS-TBNA alone. Biopsy specimens from both groups will be analyzed by pathologists. All patients will be followed up to confirm the diagnosis and to document any complications. The diagnostic yield for lung cancer and the incidence of procedure-related adverse events will be compared between the two groups.

02

Conditions studied

  • Mediastinal Metastases of Lung Cancer
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In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 240 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Third Military Medical University is the lead sponsor of 83 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged ≥18 years;
  2. Presence of at least one mediastinal lesion (short-axis diameter ≥10 mm) confirmed by thin-slice chest CT;
  3. Patients who have not undergone prior mediastinal and require further mediastinal biopsy to confirm etiology or pathological subtype, meeting at least one of the following criterias:

(1) suspected lung cancer diagnosed by two senior physicians; (2) confirmed lung cancer (requiring mediastinal staging); (3) recurrent lung cancer; 4.Patients must have completed all required preoperative laboratory tests and necessary examinations (e.g., cardiac ultrasound, CTA) to rule out ; 5. Patients are informed and capable of providing written .

Exclusion criteria

Exclusion Criteria:

  1. Presence of severe cardiopulmonary disease, coagulation disorders, massive hemoptysis, poor tolerance to anesthesia, or other related to bronchoscopy;
  2. Intraoperative endobronchial ultrasound exploration of the lesion failed to detect the target lesion despite > 20 minutes of attempts;
  3. Lesions identified as abscesses or cysts;
  4. Presence of mental illness, severe neurosis, or other conditions that preclude the provision of ;
  5. Patients who have participated in other clinical trials within 3 months;
  6. Any other conditions considered to be inappropriate to be involved in this trial.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • No intervention
    EBUS-TBNA

    Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be performed

  • Experimental
    EBUS-TBNA plus EBUS-TBMCB

    Following the completion of EBUS-TBNA, EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) will be performed.

    Procedure: EBUS-TBMCB

Interventions

  • ProcedureEBUS-TBMCB

    Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy will be performed in experimental arm following EBUS-TBNA

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What researchers measure

Primary outcomes

  1. Diagnostic yield for lung cancer

    For each biopsy modality, diagnostic yield for lung cancer is defined as the percentage of patients with eventually confirmed lung cancer (by histopathology/cytology or long-term follow-up) in whom the initial biopsy using that modality established the diagnosis.

    Time frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

Secondary outcomes

  1. Diagnostic accuracy

    Diagnostic accuracy was defined as the proportion of patients whose initial test results are consistent with the final diagnosis, based on histopathological/cytological findings and long-term follow-up assessment

    Time frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

  2. Sample size

    The area and diameter of samples obtained by each procedure

    Time frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

  3. Suitability for molecular assays

    Suitability of NSCLC samples for molecular assays

    Time frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

  4. Duration of bronchoscopic procedure

    The duration of each specific step from the start to the end of the biopsy

    Time frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months

  5. Incidence of procedure-related adverse events

    The ratio of the number of patients who had adverse events caused by the procedures and the number of all patients who have undergone EBUS procedures in each arm

    Time frame: Within 30 days post-biopsy

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Study locations

1 of 1 sites recruiting
  • Third Military Medical University
    Chongqing, Chongqing Municipality 400038, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07488507
Lead sponsor
Third Military Medical University
Responsible party
Ye Fan (Principal investigator, Third Military Medical University) — Principal investigator
First posted
Mar 23, 2026
Start date
Mar 20, 2026 (estimated)
Primary completion
Mar 1, 2030 (estimated)
Completion
Mar 1, 2030 (estimated)
Last update
Mar 23, 2026

Study contacts

Hanbing Wang
Contact
18885230175@163.com
+86 18885230175

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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