Lung CancerNCT03087305
Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA
An observational study of Lung Cancer, run by University of Minnesota at 1 site in United States.
Trial summary
Evaluation of the anatomic extent of a primary lung cancer and presence of metastasis are essential for selection of an appropriate management strategy. Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is a reliable and established technique to evaluate involvement of mediastinal lymph nodes (LN)… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Supraclavicular lymph node ultrasound
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer
Who may be able to join
- All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer
Who cannot join
- Refusal to sign consent
- Signs of skin infection along the neck
- Adults who lack the capacity to sign consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Incidence of Supraclavicular Lymph Node Metastasis in Patients Referred for EBUS-TBNA for Presumed Primary Lung Cancer by Interventional Pulmonologists.
Evaluation of the anatomic extent of a primary lung cancer and presence of metastasis are essential for selection of an appropriate management strategy. Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is a reliable and established technique to evaluate involvement of mediastinal lymph nodes (LN); however, it is an invasive procedure and may not be tolerated in patients with severe underlying lung disease. One exception is the superficially located supraclavicular lymph nodes (SCLN), which can easily be biopsied with percutaneous US-guided-fine needle aspiration (US-FNA). Traditionally, this nodal group is evaluated by palpation; however, literature suggests that palpation itself fails to capture 66% of proven disease by cytology, which challenges the acceptance that non-palpable nodes are indicative of absent disease. Since all palpable SCLN are biopsied to rule out metastasis, we may potentially up-stage more patients using ultrasound evaluation for non-palpable nodes; and offer more appropriate management. Currently, the incidence for non-palpable SCLN metastasis has not been defined in this patient population presenting for EBUS-TBNA. The primary objective is to determine the incidence of supraclavicular lymph node metastasis by ultrasound evaluation in patients referred for EBUS-TBNA.
- Conditions
- Lung Cancer
- Being tested
- Supraclavicular lymph node ultrasound
- Keywords
- Interventional Pulmonary, EBUS-TBNA, Lung cancer staging
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular lymph node ultrasoundDiagnostic test
Patients will have supraclavicular lymph node assessed prior to EBUS-TBNA
| Study group | Role | What they receive |
|---|---|---|
| 1 | All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer Receives: Diagnostic Test: Supraclavicular lymph node ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of supraclavicular metastasis
Incidence of supraclavicular metastasis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 May 2017 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Why it stopped: low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087305
- Sponsor's protocol ID
- 1703M10502
- Status last verified
- Jan 2018
- First submitted
- 15 Mar 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karsell PR, McDougall JC. Diagnostic tests for lung cancer. Mayo Clin Proc. 1993 Mar;68(3):288-96. doi: 10.1016/s0025-6196(12)60051-2.
PubMed 8474273Baatenburg de Jong RJ, Rongen RJ, Lameris JS, Harthoorn M, Verwoerd CD, Knegt P. Metastatic neck disease. Palpation vs ultrasound examination. Arch Otolaryngol Head Neck Surg. 1989 Jun;115(6):689-90. doi: 10.1001/archotol.1989.01860300043013.
PubMed 2655666Som PM, Curtin HD, Mancuso AA. Imaging-based nodal classification for evaluation of neck metastatic adenopathy. AJR Am J Roentgenol. 2000 Mar;174(3):837-44. doi: 10.2214/ajr.174.3.1740837.
PubMed 10701636Tsunodo-Shimizu H, Saida Y. Ultrasonographic visibility of supraclavicular lymph nodes in normal subjects. J Ultrasound Med. 1997 Jul;16(7):481-3. doi: 10.7863/jum.1997.16.7.481.
PubMed 9315199Vassallo P, Wernecke K, Roos N, Peters PE. Differentiation of benign from malignant superficial lymphadenopathy: the role of high-resolution US. Radiology. 1992 Apr;183(1):215-20. doi: 10.1148/radiology.183.1.1549675.
PubMed 1549675Brantigan JW, Brantigan CO, Brantigan OC. Biopsy of nonpalpable scalene lymph nodes in carcinoma of the lung. Am Rev Respir Dis. 1973 Jun;107(6):962-74. doi: 10.1164/arrd.1973.107.6.962. No abstract available.
PubMed 4712440van Overhagen H, Brakel K, Heijenbrok MW, van Kasteren JH, van de Moosdijk CN, Roldaan AC, van Gils AP, Hansen BE. Metastases in supraclavicular lymph nodes in lung cancer: assessment with palpation, US, and CT. Radiology. 2004 Jul;232(1):75-80. doi: 10.1148/radiol.2321030663. Epub 2004 May 27.
PubMed 15166326Kumaran M, Benamore RE, Vaidhyanath R, Muller S, Richards CJ, Peake MD, Entwisle JJ. Ultrasound guided cytological aspiration of supraclavicular lymph nodes in patients with suspected lung cancer. Thorax. 2005 Mar;60(3):229-33. doi: 10.1136/thx.2004.029223.
PubMed 15741441Kendirlinan R, Ozkan G, Bayram M, Bakan ND, Tutar M, Gur A, Camsari G. Ultrasound guided fine-needle aspiration biopsy of metastases in nonpalpable supraclavicular lymph nodes in lung cancer patients. Multidiscip Respir Med. 2011 Aug 31;6(4):220-5. doi: 10.1186/2049-6958-6-4-220.
PubMed 22958429Chang DB, Yang PC, Yu CJ, Kuo SH, Lee YC, Luh KT. Ultrasonography and ultrasonographically guided fine-needle aspiration biopsy of impalpable cervical lymph nodes in patients with non-small cell lung cancer. Cancer. 1992 Sep 1;70(5):1111-4. doi: 10.1002/1097-0142(19920901)70:53.0.co;2-4.
PubMed 1325269Fultz PJ, Feins RH, Strang JG, Wandtke JC, Johnstone DW, Watson TJ, Gottlieb RH, Voci SL, Rubens DJ. Detection and diagnosis of nonpalpable supraclavicular lymph nodes in lung cancer at CT and US. Radiology. 2002 Jan;222(1):245-51. doi: 10.1148/radiol.2221010431.
PubMed 11756733Lee JD, Ginsberg RJ. Lung cancer staging: the value of ipsilateral scalene lymph node biopsy performed at mediastinoscopy. Ann Thorac Surg. 1996 Aug;62(2):338-41.
PubMed 8694587
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Supraclavicular Lymph Node Metastasis in Patients Referred for EBUS-TBNA for Presumed Primary Lung Cancer by Interventional Pulmonologists.
- ClinicalTrials.gov ID
- NCT03087305
- Acronym / sponsor ID
- 1703M10502
- Conditions
- Lung Cancer
- Keywords
- Interventional Pulmonary, EBUS-TBNA, Lung cancer staging
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: low enrollment rate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the anatomic extent of a primary lung cancer and presence of metastasis are essential for selection of an appropriate management strategy. Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is a reliable and established technique to evaluate involvement of mediastinal lymph nodes (LN); however, it is an invasive procedure and may not be tolerated in patients with severe underlying lung disease. One exception is the superficially located supraclavicular lymph nodes (SCLN), which can easily be biopsied with percutaneous US-guided-fine needle aspiration (US-FNA). Traditionally, this nodal group is evaluated by palpation; however, literature suggests that palpation itself fails to capture 66% of proven disease by cytology, which challenges the acceptance that non-palpable nodes are indicative of absent disease. Since all palpable SCLN are biopsied to rule out metastasis, we may potentially up-stage more patients using ultrasound evaluation for non-palpable nodes; and offer more appropriate management. Currently, the incidence for non-palpable SCLN metastasis has not been defined in this patient population presenting for EBUS-TBNA. The primary objective is to determine the incidence of supraclavicular lymph node metastasis by ultrasound evaluation in patients referred for EBUS-TBNA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Supraclavicular lymph node ultrasoundAll patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer
Key inclusion criteria (1 listed)
- All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer
Key exclusion criteria (3 listed)
- Refusal to sign consent
- Signs of skin infection along the neck
- Adults who lack the capacity to sign consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraclavicular lymph node ultrasoundPatients will have supraclavicular lymph node assessed prior to EBUS-TBNA | Diagnostic test | 1 |
Primary outcome
Incidence of supraclavicular metastasis
Time frame: 7 days
Incidence of supraclavicular metastasis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Background: PubMed 8474273Karsell PR, McDougall JC. Diagnostic tests for lung cancer. Mayo Clin Proc. 1993 Mar;68(3):288-96. doi: 10.1016/s0025-6196(12)60051-2.
- Background: PubMed 2655666Baatenburg de Jong RJ, Rongen RJ, Lameris JS, Harthoorn M, Verwoerd CD, Knegt P. Metastatic neck disease. Palpation vs ultrasound examination. Arch Otolaryngol Head Neck Surg. 1989 Jun;115(6):689-90. doi: 10.1001/archotol.1989.01860300043013.
- Background: PubMed 10701636Som PM, Curtin HD, Mancuso AA. Imaging-based nodal classification for evaluation of neck metastatic adenopathy. AJR Am J Roentgenol. 2000 Mar;174(3):837-44. doi: 10.2214/ajr.174.3.1740837.
- Background: PubMed 9315199Tsunodo-Shimizu H, Saida Y. Ultrasonographic visibility of supraclavicular lymph nodes in normal subjects. J Ultrasound Med. 1997 Jul;16(7):481-3. doi: 10.7863/jum.1997.16.7.481.
- Background: PubMed 1549675Vassallo P, Wernecke K, Roos N, Peters PE. Differentiation of benign from malignant superficial lymphadenopathy: the role of high-resolution US. Radiology. 1992 Apr;183(1):215-20. doi: 10.1148/radiology.183.1.1549675.
- Background: PubMed 4712440Brantigan JW, Brantigan CO, Brantigan OC. Biopsy of nonpalpable scalene lymph nodes in carcinoma of the lung. Am Rev Respir Dis. 1973 Jun;107(6):962-74. doi: 10.1164/arrd.1973.107.6.962. No abstract available.
- Background: PubMed 15166326van Overhagen H, Brakel K, Heijenbrok MW, van Kasteren JH, van de Moosdijk CN, Roldaan AC, van Gils AP, Hansen BE. Metastases in supraclavicular lymph nodes in lung cancer: assessment with palpation, US, and CT. Radiology. 2004 Jul;232(1):75-80. doi: 10.1148/radiol.2321030663. Epub 2004 May 27.
- Background: PubMed 15741441Kumaran M, Benamore RE, Vaidhyanath R, Muller S, Richards CJ, Peake MD, Entwisle JJ. Ultrasound guided cytological aspiration of supraclavicular lymph nodes in patients with suspected lung cancer. Thorax. 2005 Mar;60(3):229-33. doi: 10.1136/thx.2004.029223.
- Background: PubMed 22958429Kendirlinan R, Ozkan G, Bayram M, Bakan ND, Tutar M, Gur A, Camsari G. Ultrasound guided fine-needle aspiration biopsy of metastases in nonpalpable supraclavicular lymph nodes in lung cancer patients. Multidiscip Respir Med. 2011 Aug 31;6(4):220-5. doi: 10.1186/2049-6958-6-4-220.
- Background: PubMed 1325269Chang DB, Yang PC, Yu CJ, Kuo SH, Lee YC, Luh KT. Ultrasonography and ultrasonographically guided fine-needle aspiration biopsy of impalpable cervical lymph nodes in patients with non-small cell lung cancer. Cancer. 1992 Sep 1;70(5):1111-4. doi: 10.1002/1097-0142(19920901)70:53.0.co;2-4.
- Background: PubMed 11756733Fultz PJ, Feins RH, Strang JG, Wandtke JC, Johnstone DW, Watson TJ, Gottlieb RH, Voci SL, Rubens DJ. Detection and diagnosis of nonpalpable supraclavicular lymph nodes in lung cancer at CT and US. Radiology. 2002 Jan;222(1):245-51. doi: 10.1148/radiol.2221010431.
- Background: PubMed 8694587Lee JD, Ginsberg RJ. Lung cancer staging: the value of ipsilateral scalene lymph node biopsy performed at mediastinoscopy. Ann Thorac Surg. 1996 Aug;62(2):338-41.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University of Minnesota at 1 site in United States.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of supraclavicular metastasis (time frame: 7 days). 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 NCT03087305, which also lists 12 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 1 Feb 2018.