Clara Cell ProteinNCT07338227
Validation of Clara Cell Protein as a Novel Diagnostic Biomarker for the Differentiation of Cardiogenic Pulmonary Edema From Non-Cardiogenic Pulmonary Edema
An observational study of Clara Cell Protein and Diagnostic Biomarker, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study aimed to validate the use of clara cell secretory protein (CC16) as a biomarker for differentiating between cardiogenic pulmonary edema (CPE) and non-cardiogenic pulmonary edema (NCPE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clara Cell Protein, Diagnostic Biomarker, Differentiation
- What is being tested?
- Clara cell protein 16
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2024
- 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: This study employed a prospective observational design to evaluate 100 patients receiving intubation, mechanical ventilation, and admission to the critical care department at Beni-Suef General Hospital between January 2023 and January 2024 for cardiogenic or non-cardiogenic pulmonary edema. Ethical approval was obtained from Cairo University's Faculty of Medicine.
Who may be able to join
- Adult patients aged 18 years or older.
- Both sexes.
- Patients requiring intensive care unit (ICU) admission and intubation.
- Inclusion criteria followed the American-European Consensus Conference diagnostic guidelines for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS): acute respiratory failure onset, bilateral infiltrates on chest radiography, a PaO2/FiO2 ratio below 300 for ALI or 200 for ARDS and no evidence of left atrial hypertension
Who cannot join
- Critically ill but not intubated.
- Had a mixed cause of pulmonary edema like pneumonia with heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to validate the use of clara cell secretory protein (CC16) as a biomarker for differentiating between cardiogenic pulmonary edema (CPE) and non-cardiogenic pulmonary edema (NCPE).
Read the detailed description
Club cells or Clara cells (CCs) were first described in 1881 but their importance was forgotten until Max Clara's 1937 study identifying these bronchiolar exocrine cells. CCs constitute up to 44% of proliferating small airway cells, functioning as epithelial progenitors during lung regeneration and repair of injury.
CC16 can be useful in distinguishing between cardiogenic pulmonary edema (CPE), caused by increased pressure in the heart's left ventricle, and non-cardiogenic pulmonary edema, such as acute lung injury (ALI) or acute respiratory distress syndrome (ARDS), which are not related to heart failure. Patients with ALI/ARDS tend to have lower levels of CC16 in their plasma and pulmonary edema fluid compared to those with CPE, suggesting a potential diagnostic role for CC16 in these conditions.
- Conditions
- Clara Cell Protein, Diagnostic Biomarker, Differentiation, Cardiogenic Pulmonary Edema, Non-Cardiogenic Pulmonary Edema
- Being tested
- Clara cell protein 16
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clara cell protein 16Other
Clara cell protein 16 (CC16) concentration was measured in serum samples drawn within 24 hours of intubation.
| Study group | Role | What they receive |
|---|---|---|
| CPE group | Patients with cardiogenic pulmonary edema Receives: Other: Clara cell protein 16 | |
| NCPE group | Patients with non-cardiogenic pulmonary edema. Receives: Other: Clara cell protein 16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clara cell secretory protein (CC16) level
Clara cell secretory protein (CC16) level was measured in serum samples drawn within 24 hours of intubation.
Measured: Within 24 hours of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clara Cell ProteinStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Foad Ali, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338227
- Sponsor's protocol ID
- 13/3/2024
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clara Cell Protein as a Novel Diagnostic Biomarker for the Differentiation of Cardiogenic Pulmonary Edema From Non-Cardiogenic Pulmonary Edema
- ClinicalTrials.gov ID
- NCT07338227
- Acronym / sponsor ID
- 13/3/2024
- Conditions
- Clara Cell Protein, Diagnostic Biomarker, Differentiation, Cardiogenic Pulmonary Edema, Non-Cardiogenic Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 13 Jan 2026 (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 study aimed to validate the use of clara cell secretory protein (CC16) as a biomarker for differentiating between cardiogenic pulmonary edema (CPE) and non-cardiogenic pulmonary edema (NCPE).
Detailed description
Club cells or Clara cells (CCs) were first described in 1881 but their importance was forgotten until Max Clara's 1937 study identifying these bronchiolar exocrine cells. CCs constitute up to 44% of proliferating small airway cells, functioning as epithelial progenitors during lung regeneration and repair of injury.
CC16 can be useful in distinguishing between cardiogenic pulmonary edema (CPE), caused by increased pressure in the heart's left ventricle, and non-cardiogenic pulmonary edema, such as acute lung injury (ALI) or acute respiratory distress syndrome (ARDS), which are not related to heart failure. Patients with ALI/ARDS tend to have lower levels of CC16 in their plasma and pulmonary edema fluid compared to those with CPE, suggesting a potential diagnostic role for CC16 in these conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPE group | – | Other: Clara cell protein 16Patients with cardiogenic pulmonary edema |
| NCPE group | – | Other: Clara cell protein 16Patients with non-cardiogenic pulmonary edema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study employed a prospective observational design to evaluate 100 patients receiving intubation, mechanical ventilation, and admission to the critical care department at Beni-Suef General Hospital between January 2023 and January 2024 for cardiogenic or non-cardiogenic pulmonary edema. Ethical approval was obtained from Cairo University's Faculty of Medicine.
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older.
- Both sexes.
- Patients requiring intensive care unit (ICU) admission and intubation.
- Inclusion criteria followed the American-European Consensus Conference diagnostic guidelines for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS): acute respiratory failure onset, bilateral infiltrates on chest radiography, a PaO2/FiO2 ratio below 300 for ALI or 200 for ARDS and no evidence of left atrial hypertension
Key exclusion criteria (2 listed)
- Critically ill but not intubated.
- Had a mixed cause of pulmonary edema like pneumonia with heart failure.
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 |
|---|---|---|
| Clara cell protein 16Clara cell protein 16 (CC16) concentration was measured in serum samples drawn within 24 hours of intubation. | Other | CPE group, NCPE group |
Primary outcome
Clara cell secretory protein (CC16) level
Time frame: Within 24 hours of intubation
Clara cell secretory protein (CC16) level was measured in serum samples drawn within 24 hours of intubation.
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 13 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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 Clara Cell Protein and Diagnostic Biomarker, run by Beni-Suef 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 4 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 13 Jan 2026. 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?
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?
Clara cell secretory protein (CC16) level (time frame: Within 24 hours of intubation). 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 13 Jan 2026.