Non-Small Cell Lung CancerNCT01630122
Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
An observational study of Non-Small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The goal of this study is to demonstrate the feasibility of using a novel, validated panel of Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the "A/S signature) as a diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies. Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 18 Aug 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Patients undergoing a diagnostic FNA by the following diagnostic modalities utilizing FNA: Trans-thoracic Needle Biopsy (TNB), Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA), Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA).
- Patients must have radiographic evidence for presumed lung cancer or have a previously diagnosed NSCLC with potential recurrence. Patient undergoing FNA of potential NSCLC metastatic lesions are also included (e.g., patients with hepatic metastases).
- Age >18 years. Used to define adult age who can independently provide consent.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients whose FNA biopsy is unable to provide subtype classification by pathology or is non-diagnostic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The goal of this study is to demonstrate the feasibility of using a novel, validated panel of Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the "A/S signature) as a diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies.
Objectives:
Read more
- To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.
- To define a "fixed statistical model" of histologic subtype prediction in NSCLC.
Study methods: To establish FNA biopsy requirements for gene expression-based subtype classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA biopsy according to current standard techniques . For this part of the study, approximately 40 biopsies of confirmed NSCLC will be collected for analysis.
To define a fixed statistical model of histologic subtype prediction in NSCLC, we will prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not otherwise specified (NOS), should they be encountered, may also be collected for later analysis. FNA samples qualified based on cell number or ribonucleic acid (RNA) yield (depending on the findings of our primary objective)will be assayed on the QGS platform.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Trans-thoracic Needle Biopsy (TNB), Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA), Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients newly diagnosed non small cell lung cancer | patients with presumed newly diagnosed non small cell lung cancer, where radiographic studies and clinical description favor a probable diagnosis of non small cell lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Ribonucleic acid-based molecular signature of tumor samples obtained by fine needle aspirate to discriminate subtypes of tumors relevant to treatment and outcomes.
To test a an 8-gene panel's accuracy in discriminating Non-Small Cell Lung Cancer tumors subtypes that are relevant to treatment and expected outcomes.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completion18 Aug 2015
- Study completion18 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jimmy Ruiz, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630122
- Sponsor's protocol ID
- IRB00020151
- Other IDs
- CCCWFU 97112
- Status last verified
- Jul 2018
- First submitted
- 15 Jun 2012
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
- ClinicalTrials.gov ID
- NCT01630122
- Acronym / sponsor ID
- IRB00020151
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Trans-thoracic Needle Biopsy (TNB), Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA), Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- 18 Aug 2015 (actual)
- Study completion
- 18 Aug 2015 (actual)
- First posted
- 28 Jun 2012 (estimated)
- 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.
The goal of this study is to demonstrate the feasibility of using a novel, validated panel of Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the "A/S signature) as a diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies.
Objectives:
- To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.
- To define a "fixed statistical model" of histologic subtype prediction in NSCLC.
Study methods: To establish FNA biopsy requirements for gene expression-based subtype classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA biopsy according to current standard techniques . For this part of the study, approximately 40 biopsies of confirmed NSCLC will be collected for analysis.
To define a fixed statistical model of histologic subtype prediction in NSCLC, we will prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not otherwise specified (NOS), should they be encountered, may also be collected for later analysis. FNA samples qualified based on cell number or ribonucleic acid (RNA) yield (depending on the findings of our primary objective)will be assayed on the QGS platform.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients newly diagnosed non small cell lung cancer | – | –patients with presumed newly diagnosed non small cell lung cancer, where radiographic studies and clinical description favor a probable diagnosis of non small cell lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- Patients undergoing a diagnostic FNA by the following diagnostic modalities utilizing FNA: Trans-thoracic Needle Biopsy (TNB), Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA), Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA).
- Patients must have radiographic evidence for presumed lung cancer or have a previously diagnosed NSCLC with potential recurrence. Patient undergoing FNA of potential NSCLC metastatic lesions are also included (e.g., patients with hepatic metastases).
- Age >18 years. Used to define adult age who can independently provide consent.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (1 listed)
- Patients whose FNA biopsy is unable to provide subtype classification by pathology or is non-diagnostic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Use of Ribonucleic acid-based molecular signature of tumor samples obtained by fine needle aspirate to discriminate subtypes of tumors relevant to treatment and outcomes.
Time frame: Day 1
To test a an 8-gene panel's accuracy in discriminating Non-Small Cell Lung Cancer tumors subtypes that are relevant to treatment and expected outcomes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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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.
Jimmy Ruiz, MD principal investigator
Wake Forest University Health Sciences
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 Non-Small Cell Lung Cancer, run by Wake Forest University Health Sciences 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 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: finished, as of the sponsor's last update on 3 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Use of Ribonucleic acid-based molecular signature of tumor samples obtained by fine needle aspirate to discriminate subtypes of tumors relevant to treatment and outcomes. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2018.