Pleural ThickeningNCT05701462
Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings
A study testing biopsy under sonographic gidance in people with Pleural Thickening, run by Sohag University at 1 site in Egypt.
Trial summary
pleura is a serous membrane, it consist of parietal pleura and visceral pleura. pleural thickening is any form of thickening involving the pleura more than 3 mm. there is malignant thickening : methoselioma, metastasis and non malignant thickening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Thickening
- What is being tested?
- biopsy under sonographic gidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to Jan 2024
- 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
- Adult patients diagnosed as having pleural thickening with or without pleural effusion.
Who cannot join
- Emphysema or contraindication to pleural biopsy
Trial locations and contacts
1 site in 1 country.
Mohammed T Solyman, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
magdy m amin, professor
About this study
pleura is a serous membrane, it consist of parietal pleura and visceral pleura. pleural thickening is any form of thickening involving the pleura more than 3 mm.
there is malignant thickening : methoselioma, metastasis and non malignant thickening.
trans thoracic USn is a reliable , safe and gold standard for studying pleura.
- Conditions
- Pleural Thickening
- Being tested
- biopsy under sonographic gidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy under sonographic gidanceDiagnostic test
pleural biopsy under sonographic guidance
| Study group | Role | What they receive |
|---|---|---|
| pleural disease | Experimental | Not described Receives: Diagnostic Test: biopsy under sonographic gidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of sonography in pleural thickening in comparison to CT and histopathology
sensitivity of sonography in cases of pleural thickening in comparison to CT findings and histopathology
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Jan 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pleural ThickeningStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Harby Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701462
- Sponsor's protocol ID
- Soh-Med-23-01-04
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Porcel JM. Pleural ultrasound for clinicians. Rev Clin Esp (Barc). 2016 Nov;216(8):427-435. doi: 10.1016/j.rce.2016.05.009. Epub 2016 Jun 6. English, Spanish.
PubMed 27282205Hallifax RJ, Haris M, Corcoran JP, Leyakathalikhan S, Brown E, Srikantharaja D, Manuel A, Gleeson FV, Munavvar M, Rahman NM. Role of CT in assessing pleural malignancy prior to thoracoscopy. Thorax. 2015 Feb;70(2):192-3. doi: 10.1136/thoraxjnl-2014-206054. Epub 2014 Jul 30.
PubMed 25077699Sureka B, Thukral BB, Mittal MK, Mittal A, Sinha M. Radiological review of pleural tumors. Indian J Radiol Imaging. 2013 Oct;23(4):313-20. doi: 10.4103/0971-3026.125577.
PubMed 24604935Pairon JC, Laurent F, Rinaldo M, Clin B, Andujar P, Ameille J, Brochard P, Chammings S, Ferretti G, Galateau-Salle F, Gislard A, Letourneux M, Luc A, Schorle E, Paris C. Pleural plaques and the risk of pleural mesothelioma. J Natl Cancer Inst. 2013 Feb 20;105(4):293-301. doi: 10.1093/jnci/djs513. Epub 2013 Jan 25.
PubMed 23355760
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings
- ClinicalTrials.gov ID
- NCT05701462
- Acronym / sponsor ID
- Soh-Med-23-01-04
- Conditions
- Pleural Thickening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 27 Jan 2023 (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.
pleura is a serous membrane, it consist of parietal pleura and visceral pleura. pleural thickening is any form of thickening involving the pleura more than 3 mm.
there is malignant thickening : methoselioma, metastasis and non malignant thickening.
trans thoracic USn is a reliable , safe and gold standard for studying pleura.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pleural disease | Experimental | Diagnostic Test: biopsy under sonographic gidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients diagnosed as having pleural thickening with or without pleural effusion.
Key exclusion criteria (1 listed)
- Emphysema or contraindication to pleural biopsy
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 |
|---|---|---|
| biopsy under sonographic gidancepleural biopsy under sonographic guidance | Diagnostic test | pleural disease |
Primary outcome
sensitivity of sonography in pleural thickening in comparison to CT and histopathology
Time frame: one year
sensitivity of sonography in cases of pleural thickening in comparison to CT findings and histopathology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 27282205Porcel JM. Pleural ultrasound for clinicians. Rev Clin Esp (Barc). 2016 Nov;216(8):427-435. doi: 10.1016/j.rce.2016.05.009. Epub 2016 Jun 6. English, Spanish.
- Background: PubMed 25077699Hallifax RJ, Haris M, Corcoran JP, Leyakathalikhan S, Brown E, Srikantharaja D, Manuel A, Gleeson FV, Munavvar M, Rahman NM. Role of CT in assessing pleural malignancy prior to thoracoscopy. Thorax. 2015 Feb;70(2):192-3. doi: 10.1136/thoraxjnl-2014-206054. Epub 2014 Jul 30.
- Background: PubMed 24604935Sureka B, Thukral BB, Mittal MK, Mittal A, Sinha M. Radiological review of pleural tumors. Indian J Radiol Imaging. 2013 Oct;23(4):313-20. doi: 10.4103/0971-3026.125577.
- Background: PubMed 23355760Pairon JC, Laurent F, Rinaldo M, Clin B, Andujar P, Ameille J, Brochard P, Chammings S, Ferretti G, Galateau-Salle F, Gislard A, Letourneux M, Luc A, Schorle E, Paris C. Pleural plaques and the risk of pleural mesothelioma. J Natl Cancer Inst. 2013 Feb 20;105(4):293-301. doi: 10.1093/jnci/djs513. Epub 2013 Jan 25.
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.
Mohammed T Solyman, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy under sonographic gidance in people with Pleural Thickening, run by Sohag University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 27 Jan 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa H Mohammoed, resident (01008803318, asmaa011047@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of sonography in pleural thickening in comparison to CT and histopathology (time frame: one year). 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 NCT05701462, which also lists 4 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 27 Jan 2023.