Pectus ExcavatumNCT02552186
Non-invasive Clinical Pectus Index as a Measurement of Severity in Pectus
A study testing Caliper measurement in people with Pectus Excavatum, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial summary
Pectus excavatum (PE), the most common congenital chest wall deformity, requires surgical repair when the degree of deformity is severe. Currently, the Pectus Index (PI) is used to classify PE severity. Read more about this study
- Who is it for?
- Ages 11 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Caliper measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2020
- 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 11 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Group A (PE Group): All patients evaluated in the ACH JHM Pediatric Surgery or Cardiac Surgery Clinics, as well as in the outpatient clinic system at Johns Hopkins Hospital, for surgical correction of Pectus Excavatum.
- Group B (Control Group): Age and gender matched patients who undergo chest CT at the ACH JHM Radiology Department for indications other than Pectus Excavatum.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Pectus excavatum (PE), the most common congenital chest wall deformity, requires surgical repair when the degree of deformity is severe. Currently, the Pectus Index (PI) is used to classify PE severity. Calculation of the PI requires cross-sectional imaging of the chest, usually with computed tomography (CT) or Magnetic Resonance Imaging (MRI), to obtain the necessary measurements. However, CT delivers a high dose of ionizing radiation, which carries cumulative long-term risks of malignancy and MRI can be costly. The purpose of this study is to develop a method whereby accurate chest wall measurements can be obtained to quantify PE severity without the need for cross-sectional imaging.
Read the detailed description
This is a prospective study. The study population will consist of 2 groups. The first group (PE Group) will consist of patients presenting to the Johns Hopkins All Children's Hospital (JHACH) Pediatric Surgery or Cardiac Surgery Clinics and the outpatient clinic system at Johns Hopkins Hospital for evaluation of pectus excavatum. The second group (Control Group) will be age and gender matched patients presenting to the Radiology department of JHACH undergoing CT chest for indications other than chest wall deformity. Clinical caliper measurements will be taken and used to calculate the Clinical PI.
The steps to obtain the clinical caliper measurements are as follows: With the subject lying down, a ruler will be placed across the chest and a second ruler will be used to measure the depth at the deepest point of the sternum. The 2nd ruler will then be used to measure the height of the horizontal ruler to the bed on both sides. All measurements will be made on end expiration. With the subject standing, a measuring tape will be placed around the chest at the point of the deepest sternal depression. The sternum, spine and the bilateral lateral chest locations will be marked with temporary ink. The tape will be kept as level as possible. Chest calipers will be used to measure from deepest point of sternum to posterior midline, posterior midline to anterior chest and the transverse chest diameter. Each measurement will be taken at end expiration. The circumference of the chest will be recorded.
Each set of measurements will be taken by 2 independent members of the research team. Attempts will be made to record the amount of time it takes to obtain the measurements. Consent will be obtained to photograph the process for illustrative purposes. Every attempt will be made to conceal the patient's identity by excluding the face from the photograph. In instances where the face is not able to be excluded, the facial features will be blurred.
Clinical measurements may be recorded during routine medical care at the provider's discretion. However, these measurements will be considered research procedures for the purposes of this trial. A copy of the measurements will be placed in the medical chart of subjects evaluated for PE for the provider's future reference. Measurements obtained in the Control group will be strictly for the purposes of the research protocol. All subjects, regardless of group, will be provided standard of care for all other medical conditions.
All CT and MRI performed for both PE and Control groups will be reviewed and the PI will be determined by a single, blinded radiologist. The radiologist determining the PI may not be the interpreting radiologist and will have no responsibility to provide a comprehensive interpretation of the study. The PI as determined by the research radiologist will be recorded separately from the subject's EMR in a research file. Having a single, blinded radiologist determine the PI for the entire research cohort will allow for consistency in determining the PI, as this is the gold standard to which we are comparing our clinical measurements.
- Conditions
- Pectus Excavatum
- Being tested
- Caliper measurement
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caliper measurementOther
Clinical caliper measurements will be taken and used to calculate the Clinical PI
| Study group | Role | What they receive |
|---|---|---|
| Pectus Excavatum Group | Active comparator | The first group (PE Group) will consist of patients presenting to the All Children's Hospital Johns Hopkins Medicine (ACH JHM) Pediatric Surgery or Cardiac Surgery Clinics and the outpatient clinic system at Johns Hopkins Hospital for evaluation of pectus excavatum. Clinical measurements will be obtained using calipers. Receives: Other: Caliper measurement |
| Control Group | No intervention | The second group (Control Group) will be age and gender matched patients presenting to the Radiology department of ACH JHM undergoing CT chest for indications other than chest wall deformity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of clinically-derived threshold versus CT/MRI-derived thresholds
Sensitivity refers to the ability of the test to correctly identify those patients with the disease.
Measured: 5 years
Specificity of clinically-derived threshold versus CT/MRI-derived thresholds
Specificity refers to the ability of the test to correctly identify those patients without the disease.
Measured: 5 years
Receiver operator characteristic curve of clinically-derived threshold versus CT/MRI-derived thresholds
plot of the true positive rate against the false positive rate for the different possible cutpoints of a diagnostic test.
Measured: 5 years
Secondary outcomes (3)
Correlation coefficient
statistical measure of the strength of the relationship between the relative movements of two variables.
Measured: 5 years
Cohen's Kappa coefficient
a statistic which measures inter-rater agreement for qualitative (categorical) items. It
Measured: 5 years
Agreement between Clinical Pectus Index (CPI) and Pectus Index (PI)-derived from CT or MRI
determine how well each measure identifies the outcome desired
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Chandler, MD, Principal investigator, JHACH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552186
- Sponsor's protocol ID
- IRB00067521
- Status last verified
- Jun 2023
- First submitted
- 15 Sep 2015
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Clinical Pectus Index as a Measurement of Severity in Pectus
- ClinicalTrials.gov ID
- NCT02552186
- Acronym / sponsor ID
- IRB00067521
- Conditions
- Pectus Excavatum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 17 Sep 2015 (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.
Pectus excavatum (PE), the most common congenital chest wall deformity, requires surgical repair when the degree of deformity is severe. Currently, the Pectus Index (PI) is used to classify PE severity. Calculation of the PI requires cross-sectional imaging of the chest, usually with computed tomography (CT) or Magnetic Resonance Imaging (MRI), to obtain the necessary measurements. However, CT delivers a high dose of ionizing radiation, which carries cumulative long-term risks of malignancy and MRI can be costly. The purpose of this study is to develop a method whereby accurate chest wall measurements can be obtained to quantify PE severity without the need for cross-sectional imaging.
Detailed description
This is a prospective study. The study population will consist of 2 groups. The first group (PE Group) will consist of patients presenting to the Johns Hopkins All Children's Hospital (JHACH) Pediatric Surgery or Cardiac Surgery Clinics and the outpatient clinic system at Johns Hopkins Hospital for evaluation of pectus excavatum. The second group (Control Group) will be age and gender matched patients presenting to the Radiology department of JHACH undergoing CT chest for indications other than chest wall deformity. Clinical caliper measurements will be taken and used to calculate the Clinical PI.
The steps to obtain the clinical caliper measurements are as follows: With the subject lying down, a ruler will be placed across the chest and a second ruler will be used to measure the depth at the deepest point of the sternum. The 2nd ruler will then be used to measure the height of the horizontal ruler to the bed on both sides. All measurements will be made on end expiration. With the subject standing, a measuring tape will be placed around the chest at the point of the deepest sternal depression. The sternum, spine and the bilateral lateral chest locations will be marked with temporary ink. The tape will be kept as level as possible. Chest calipers will be used to measure from deepest point of sternum to posterior midline, posterior midline to anterior chest and the transverse chest diameter. Each measurement will be taken at end expiration. The circumference of the chest will be recorded.
Each set of measurements will be taken by 2 independent members of the research team. Attempts will be made to record the amount of time it takes to obtain the measurements. Consent will be obtained to photograph the process for illustrative purposes. Every attempt will be made to conceal the patient's identity by excluding the face from the photograph. In instances where the face is not able to be excluded, the facial features will be blurred.
Clinical measurements may be recorded during routine medical care at the provider's discretion. However, these measurements will be considered research procedures for the purposes of this trial. A copy of the measurements will be placed in the medical chart of subjects evaluated for PE for the provider's future reference. Measurements obtained in the Control group will be strictly for the purposes of the research protocol. All subjects, regardless of group, will be provided standard of care for all other medical conditions.
All CT and MRI performed for both PE and Control groups will be reviewed and the PI will be determined by a single, blinded radiologist. The radiologist determining the PI may not be the interpreting radiologist and will have no responsibility to provide a comprehensive interpretation of the study. The PI as determined by the research radiologist will be recorded separately from the subject's EMR in a research file. Having a single, blinded radiologist determine the PI for the entire research cohort will allow for consistency in determining the PI, as this is the gold standard to which we are comparing our clinical measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectus Excavatum Group | Active comparator | Other: Caliper measurementThe first group (PE Group) will consist of patients presenting to the All Children's Hospital Johns Hopkins Medicine (ACH JHM) Pediatric Surgery or Cardiac Surgery Clinics and the outpatient clinic system at Johns Hopkins Hospital for evaluation of pectus excavatum. Clinical measurements will be obtained using calipers. |
| Control Group | No intervention | –The second group (Control Group) will be age and gender matched patients presenting to the Radiology department of ACH JHM undergoing CT chest for indications other than chest wall deformity. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Group A (PE Group): All patients evaluated in the ACH JHM Pediatric Surgery or Cardiac Surgery Clinics, as well as in the outpatient clinic system at Johns Hopkins Hospital, for surgical correction of Pectus Excavatum.
- Group B (Control Group): Age and gender matched patients who undergo chest CT at the ACH JHM Radiology Department for indications other than Pectus Excavatum.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Caliper measurementClinical caliper measurements will be taken and used to calculate the Clinical PI | Other | Pectus Excavatum Group |
Primary outcome
Sensitivity of clinically-derived threshold versus CT/MRI-derived thresholds
Time frame: 5 years
Sensitivity refers to the ability of the test to correctly identify those patients with the disease.
Specificity of clinically-derived threshold versus CT/MRI-derived thresholds
Time frame: 5 years
Specificity refers to the ability of the test to correctly identify those patients without the disease.
Receiver operator characteristic curve of clinically-derived threshold versus CT/MRI-derived thresholds
Time frame: 5 years
plot of the true positive rate against the false positive rate for the different possible cutpoints of a diagnostic test.
3 secondary outcomes
Correlation coefficient
Time frame: 5 years
Cohen's Kappa coefficient
Time frame: 5 years
Agreement between Clinical Pectus Index (CPI) and Pectus Index (PI)-derived from CT or MRI
Time frame: 5 years
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 2023.
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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.
Nicole Chandler, MD principal investigator
JHACH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caliper measurement in people with Pectus Excavatum, run by Johns Hopkins All Children's Hospital 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 2 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 2023. 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?
Sensitivity of clinically-derived threshold versus CT/MRI-derived thresholds (time frame: 5 years). The study lists 3 primary outcomes in all. 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 2023.