Chest--DiseasesNCT06074978
Early Detection of Lung Cancer In Patients With Chronic Chest Diseases
An observational study of Chest--Diseases, run by Assiut University.
Trial summary
To evaluate the effectiveness of LDCT in detecting early-stage lung cancer in patients with chronic lung conditions compared to standard chest x-rays. To improve lung cancer outcomes through optimized use of radiological technologies for early detection in high-risk patients with pre-existing lung conditions. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chest--Diseases
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 20 Dec 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: After taking the informed consent, full history was taken from all patients participating in the study. Detailed clinical examination and routine laboratory investigations (complete blood count, liver function test, urea, creatinine and ESR) will be done. * Radiological imaging technologies -Low Dose Computed tomography (CT scans), chest x-rays These are used to detect and characterize lung abnormalities. * Pulmonary function tests - Spirometry volume measurements, diffusion capacity testing. These assess lung health and function in patients with chronic lung conditions
Who may be able to join
- 1- Chronic chest diseases Patients .
Who cannot join
- 1 - Age: less than 45 years. 2-Patients diagnosed with lung cancer 3-Unstable patients or need for ICU admission
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radiological Early Detection of Lung Cancer In Patients With Chronic Chest Diseases.
- To evaluate the effectiveness of LDCT in detecting early-stage lung cancer in patients with chronic lung conditions compared to standard chest x-rays.
- To improve lung cancer outcomes through optimized use of radiological technologies for early detection in high-risk patients with pre-existing lung conditions.
Read the detailed description
The early detection of lung cancer is crucial, as it is one of the most common and deadly types of cancer worldwide. Early detection is especially important in patients with chronic chest diseases, as these underlying conditions can make lung cancer more difficult to diagnose at later stages. Radiological imaging techniques play a key role in the early detection of lung cancer in this high-risk patient population.
Recent advances in imaging technologies have improved our ability to detect small lung abnormalities indicative of cancer at earlier stages, even before symptoms appear . Techniques such as low-dose CT scanning have been shown to reduce lung cancer mortality by up to 20% compared to chest radiography alone . Advanced imaging allows clinicians to identify subtle nodules or masses in the lungs that may represent cancer .
Determining the type, size, and extent of lung lesions is important for prognosis and treatment planning . Imaging technologies help characterize lesions as benign or malignant and determine cancer stage . This information guides decisions around surgery, chemotherapy, radiation therapy, or other interventions .
Early detection through radiological screening has been associated with improved survival rates for lung cancer patients with chronic lung diseases . Screening finds a higher portion of early-stage, potentially curable cancers in this high-risk group . Overall, advanced imaging techniques play a vital role in the early detection and management of lung cancer in patients with underlying chronic chest conditions.
- Conditions
- Chest--Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection early-stage lung cancer (Stage I/II) • Lung • Lung cancer mortality rate
By LDCT
Measured: baseline
Secondary outcomes (1)
• Diagnostic accuracy of imaging modalities • Positive predictive value of screening tests • Rate of unnecessary invasive procedures • Identification of high-risk subgroups
BY statiscal anylasis from results
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start20 Dec 2023 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest--DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
- Investigators
- Mustafa sayed, lecture, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074978
- Sponsor's protocol ID
- LDCT &chest diseases
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balkan A, Bulut Y, Fuhrman CR, Fisher SN, Wilson DO, Weissfeld JL, Sciurba FC. COPD phenotypes in a lung cancer screening population. Clin Respir J. 2016 Jan;10(1):48-53. doi: 10.1111/crj.12180. Epub 2014 Jul 28.
PubMed 24989058Jogi J, Markstad H, Tufvesson E, Bjermer L, Bajc M. The added value of hybrid ventilation/perfusion SPECT/CT in patients with stable COPD or apparently healthy smokers. Cancer-suspected CT findings in the lungs are common when hybrid imaging is used. Int J Chron Obstruct Pulmon Dis. 2014 Dec 18;10:25-30. doi: 10.2147/COPD.S73423. eCollection 2015.
PubMed 25565797
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Early Detection of Lung Cancer In Patients With Chronic Chest Diseases.
- ClinicalTrials.gov ID
- NCT06074978
- Acronym / sponsor ID
- LDCT &chest diseases
- Conditions
- Chest--Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 10 Oct 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.
- To evaluate the effectiveness of LDCT in detecting early-stage lung cancer in patients with chronic lung conditions compared to standard chest x-rays.
- To improve lung cancer outcomes through optimized use of radiological technologies for early detection in high-risk patients with pre-existing lung conditions.
Detailed description
The early detection of lung cancer is crucial, as it is one of the most common and deadly types of cancer worldwide. Early detection is especially important in patients with chronic chest diseases, as these underlying conditions can make lung cancer more difficult to diagnose at later stages. Radiological imaging techniques play a key role in the early detection of lung cancer in this high-risk patient population.
Recent advances in imaging technologies have improved our ability to detect small lung abnormalities indicative of cancer at earlier stages, even before symptoms appear . Techniques such as low-dose CT scanning have been shown to reduce lung cancer mortality by up to 20% compared to chest radiography alone . Advanced imaging allows clinicians to identify subtle nodules or masses in the lungs that may represent cancer .
Determining the type, size, and extent of lung lesions is important for prognosis and treatment planning . Imaging technologies help characterize lesions as benign or malignant and determine cancer stage . This information guides decisions around surgery, chemotherapy, radiation therapy, or other interventions .
Early detection through radiological screening has been associated with improved survival rates for lung cancer patients with chronic lung diseases . Screening finds a higher portion of early-stage, potentially curable cancers in this high-risk group . Overall, advanced imaging techniques play a vital role in the early detection and management of lung cancer in patients with underlying chronic chest conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- After taking the informed consent, full history was taken from all patients participating in the study. Detailed clinical examination and routine laboratory investigations (complete blood count, liver function test, urea, creatinine and ESR) will be done. * Radiological imaging technologies -Low Dose Computed tomography (CT scans), chest x-rays These are used to detect and characterize lung abnormalities. * Pulmonary function tests - Spirometry volume measurements, diffusion capacity testing. These assess lung health and function in patients with chronic lung conditions
Key inclusion criteria (1 listed)
- 1- Chronic chest diseases Patients .
Key exclusion criteria (1 listed)
- 1 - Age: less than 45 years. 2-Patients diagnosed with lung cancer 3-Unstable patients or need for ICU admission
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
Detection early-stage lung cancer (Stage I/II) • Lung • Lung cancer mortality rate
Time frame: baseline
By LDCT
1 secondary outcome
• Diagnostic accuracy of imaging modalities • Positive predictive value of screening tests • Rate of unnecessary invasive procedures • Identification of high-risk subgroups
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 24989058Balkan A, Bulut Y, Fuhrman CR, Fisher SN, Wilson DO, Weissfeld JL, Sciurba FC. COPD phenotypes in a lung cancer screening population. Clin Respir J. 2016 Jan;10(1):48-53. doi: 10.1111/crj.12180. Epub 2014 Jul 28.
- Background: PubMed 25565797Jogi J, Markstad H, Tufvesson E, Bjermer L, Bajc M. The added value of hybrid ventilation/perfusion SPECT/CT in patients with stable COPD or apparently healthy smokers. Cancer-suspected CT findings in the lungs are common when hybrid imaging is used. Int J Chron Obstruct Pulmon Dis. 2014 Dec 18;10:25-30. doi: 10.2147/COPD.S73423. eCollection 2015.
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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.
Mustafa sayed, lecture study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Chest--Diseases, run by Assiut University.
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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Hend saleh, lecture (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection early-stage lung cancer (Stage I/II) • Lung • Lung cancer mortality rate (time frame: baseline). 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 NCT06074978, which also lists 2 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 7 Nov 2023.