Malignant NeoplasmNCT03868579
Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy
A study testing Biopsy, Medical Chart Review and Thoracoscopy in people with Malignant Neoplasm and Malignant Respiratory Tract Neoplasm, run by M.D. Anderson Cancer Center at 4 sites in 2 countries.
Trial summary
This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Malignant Respiratory Tract Neoplasm, Malignant Thoracic Neoplasm
- What is being tested?
- Biopsy, Medical Chart Review and Thoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Jan 2018to 27 Feb 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients who will undergo pleuroscopy with biopsy
Who cannot join
- Patients with known malignant pleural effusion
- Inability or unwillingness to give informed consent
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
M D Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Study to Evaluate the Diagnostic Performance of Pleural Touch Preparations in Pleuroscopy, a Prospective Study
This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. A type of laboratory testing called rapid on site evaluation of pleural touch preparations that uses pleural biopsy tissue samples collected during an already-scheduled pleuroscopy may be able to diagnose malignant pleural effusion.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.
SECONDARY OBJECTIVES:
- To estimate the sensitivity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.
II. To estimate the specificity and sensitivity of visual assessment of pleura for predicting malignancy on final pathology in pleuroscopy.
III. To compare the specificity and sensitivity of ROSE of touch preps between centers.
OUTLINE:
Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
- Being tested
- Biopsy, Medical Chart Review, Thoracoscopy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Bx
Undergo biopsy
Medical Chart ReviewOther
Also called Chart Review
Review medical chart
ThoracoscopyProcedure or surgery
Undergo pleuroscopy
| Study group | Role | What they receive |
|---|---|---|
| Observational (pleuroscopy, medical chart review) | Experimental | Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed. Receives: Procedure: Biopsy; Other: Medical Chart Review; Procedure: Thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy
Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and standard deviations [SDs]) along with 95% confidence intervals (CIs) for the means or proportions will be computed for the measures of interest. Specificity will be defined as true negative (TN) divided by (TN + false positive [FP]). High probability of malignancy is defined as adequate tissue with tumor present. Low probability of malignancy defined is adequate tissue with no tumor present. Indeterminate probability of malignancy is defined as presence of atypical cells but inadequate for a definitive diagnosis on ROSE. Will collapse the indeterminate probability of malignancy (atypical cells category) found on touch preps into low probability for malignancy bin and indeterminate probability of malignancy on visual assessment into low probability for malignancy.
Measured: Up to 1 year
Secondary outcomes (7)
Sensitivity of ROSE of preps for predicting malignancy
Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and SDs) along with 95% CIs for the means or proportions will be computed for the measures of interest. Sensitivity will be defined as true positive (TP) divided by (TP + false negative [FN]). High probability of malignancy is defined as adequate tissue with tumor present. Low probability of malignancy defined is adequate tissue with no tumor present. Indeterminate probability of malignancy is defined as presence of atypical cells but inadequate for a definitive diagnosis on ROSE. Will collapse the indeterminate probability of malignancy (atypical cells category) found on touch preps into low probability for malignancy bin and indeterminate probability of malignancy on visual assessment into low probability for malignancy.
Measured: Up to 1 year
Specificity of visual assessment of pleura for predicting malignancy
Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and SDs) along with 95% CIs for the means or proportions will be computed for the measures of interest. Specificity will be defined as TN divided by (TN + FP). High probability of malignancy is defined as presence of abnormalities, such as studding, presence of parietal or visceral masses or nodules, or abnormal tissue deposits consistent with malignancy. Low probability is defined as absence of abnormalities or presence of purulent, fibrino-purulent pleural fluid or parietal and/or visceral pleura inflammation or thickening. Indeterminate probability is defined as findings which cannot include or exclude malignancy with certainty, such as inflammation of the pleura or adhesions, but that cannot be classified by the interventionist in any of the above categories. Will collapse the indeterminate probability of malignancy on visual assessment into low probability for malignancy.
Measured: Up to 1 year
Sensitivity of visual assessment of pleura for predicting malignancy
Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and SDs) along with 95% CIs for the means or proportions will be computed for the measures of interest. Sensitivity will be defined as TP divided by (TP + FN). High probability of malignancy is defined as presence of abnormalities, such as studding, presence of parietal or visceral masses or nodules, or abnormal tissue deposits consistent with malignancy. Low probability is defined as absence of abnormalities or presence of purulent, fibrino-purulent pleural fluid or parietal and/or visceral pleura inflammation or thickening. Indeterminate probability is defined as findings which cannot include or exclude malignancy with certainty, such as inflammation of the pleura or adhesions, but that cannot be classified by the interventionist in any of the above categories. Will collapse the indeterminate probability of malignancy on visual assessment into low probability for malignancy.
Measured: Up to 1 year
Positive predictive value (PPV) for all patients
PPV will be defined as TP divided by (TP + FP). Pre-test odds will be calculated using the formula: pre-test probability divided by (1 - pre-test probability). Post-test odds will be calculated using the formula: pre-test odds times likelihood ratio, and post-test probability was calculated using the formula: post-test odds divided by (1 + post-test odds). Likelihood ratios (LRs) will also be calculated by dividing the probability of a result in patients with the disease by the probability of the same result in patients without the disease.
Measured: Up to 1 year
Negative predictive value (NPV) for all patients
NPV will be defined as TN divided by (TN + FN). Pre-test odds will be calculated using the formula: pre-test probability divided by (1 - pre-test probability). Post-test odds will be calculated using the formula: pre-test odds times likelihood ratio, and post-test probability was calculated using the formula: post-test odds divided by (1 + post-test odds). LRs will also be calculated by dividing the probability of a result in patients with the disease by the probability of the same result in patients without the disease.
Measured: Up to 1 year
Specificity of ROSE on touch preps between centers
Will be compared between centers using Chi-squared and Fisher exact tests.
Measured: Up to 1 year
Sensitivity of ROSE on touch preps between centers
Will be compared between centers using Chi-squared and Fisher exact tests.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start10 Jan 2018
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Horiana Grosu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868579
- Sponsor's protocol ID
- 2017-0746
- Other IDs
- NCI-2019-00735, 2017-0746
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2019
- Last updated
- 5 Mar 2025
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Diagnostic Performance of Pleural Touch Preparations in Pleuroscopy, a Prospective Study
- ClinicalTrials.gov ID
- NCT03868579
- Acronym / sponsor ID
- 2017-0746
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 11 Mar 2019 (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.
This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. A type of laboratory testing called rapid on site evaluation of pleural touch preparations that uses pleural biopsy tissue samples collected during an already-scheduled pleuroscopy may be able to diagnose malignant pleural effusion.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.
SECONDARY OBJECTIVES:
- To estimate the sensitivity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.
II. To estimate the specificity and sensitivity of visual assessment of pleura for predicting malignancy on final pathology in pleuroscopy.
III. To compare the specificity and sensitivity of ROSE of touch preps between centers.
OUTLINE:
Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (pleuroscopy, medical chart review) | Experimental | Procedure: Biopsy, Other: Medical Chart Review, Procedure: ThoracoscopyPatients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo pleuroscopy with biopsy
Key exclusion criteria (2 listed)
- Patients with known malignant pleural effusion
- Inability or unwillingness to give informed 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 |
|---|---|---|
| BiopsyAlso: BxUndergo biopsy | Procedure or surgery | Observational (pleuroscopy, medical chart review) |
| Medical Chart ReviewAlso: Chart ReviewReview medical chart | Other | Observational (pleuroscopy, medical chart review) |
| ThoracoscopyUndergo pleuroscopy | Procedure or surgery | Observational (pleuroscopy, medical chart review) |
Primary outcome
Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy
Time frame: Up to 1 year
Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and standard deviations [SDs]) along with 95% confidence intervals (CIs) for the means or proportions will be computed for the measures of interest. Specificity will be defined as true negative (TN) divided by (TN + false positive [FP]). High probability of malignancy is defined as adequate tissue with tumor present. Low probability of malignancy defined is adequate tissue with no tumor present. Indeterminate probability of malignancy is defined as presence of atypical cells but inadequate for a definitive diagnosis on ROSE. Will collapse the indeterminate probability of malignancy (atypical cells category) found on touch preps into low probability for malignancy bin and indeterminate probability of malignancy on visual assessment into low probability for malignancy.
7 secondary outcomes
Sensitivity of ROSE of preps for predicting malignancy
Time frame: Up to 1 year
Specificity of visual assessment of pleura for predicting malignancy
Time frame: Up to 1 year
Sensitivity of visual assessment of pleura for predicting malignancy
Time frame: Up to 1 year
Positive predictive value (PPV) for all patients
Time frame: Up to 1 year
Negative predictive value (NPV) for all patients
Time frame: Up to 1 year
Specificity of ROSE on touch preps between centers
Time frame: Up to 1 year
Sensitivity of ROSE on touch preps between centers
Time frame: Up to 1 year
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 5 Mar 2025.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Horiana Grosu principal investigator
M.D. Anderson Cancer Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Medical Chart Review and Thoracoscopy in people with Malignant Neoplasm and Malignant Respiratory Tract Neoplasm, run by M.D. Anderson Cancer Center at 4 sites in 2 countries.
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 2 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Cyprus. 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?
Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy (time frame: Up to 1 year). 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 5 Mar 2025.