Breast Cancer FemaleNCT06196216
Breast Lesion in CT Chest
An observational study of Breast Cancer Female, run by Assiut University at 1 site in Egypt.
Trial summary
The aims of this study are To evaluate the CT features of incidental breast lesions on chest CT and subsequently suggest useful criteria for referral to a specialized breast unit. Read more about this study
- Who is it for?
- Ages 25 to 95 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- MSCT
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 95 years
- Women only
- Adult, Older adult
Study population: adult female patients who underwent enhanced CT chest that incidentally revealed breast lesion(s) then referred to a specialized breast centre and had histopathological diagnosis.
Who may be able to join
- Inclusion criteria are patients who ex hibited incidental breast lesion(s) on enhanced chest CT and were referred to a specialized breast unit for assessment and then underwent pathological confirmation.
Who cannot join
- -Patients with known breast dis ease.
- Previous history of breast cancer or breast surgery.
- Patients who had undergone only non-enhanced CT examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Referal Features of Incidental Breast Masses in Chest CT
The aims of this study are To evaluate the CT features of incidental breast lesions on chest CT and subsequently suggest useful criteria for referral to a specialized breast unit.
Read the detailed description
Enhanced chest CT examination reports containing the key word 'breast' well be reviewed retrospectively. Patients who had incidental breast lesion and were referred to a specialized breast unit and then underwent pathological confirmation well be included. Finally, 100 patients well be enrolled. Two radiologists well evaluate lesion characteristics including; size, shape, margins and enhancement. The correlations between the CT features and pathologies well be evaluated and the diagnostic accuracy of CT features in various combinations well be assessed.
- Conditions
- Breast Cancer Female
- Being tested
- MSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCTRadiation
Enhanced CT chest
What is being measured
The primary outcome is the main question the study is designed to answer.
detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit
detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start20 Dec 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (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 Breast Cancer FemaleStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Mohamed Ali, Assiut University
- Investigators
- Abo-Elhassan Hassib Mohamed, Associate professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196216
- Sponsor's protocol ID
- CT chest in breast cancer
- Status last verified
- Dec 2023
- First submitted
- 24 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
PubMed 25328522Harish MG, Konda SD, MacMahon H, Newstead GM. Breast lesions incidentally detected with CT: what the general radiologist needs to know. Radiographics. 2007 Oct;27 Suppl 1:S37-51. doi: 10.1148/rg.27si075510.
PubMed 18180233
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Referal Features of Incidental Breast Masses in Chest CT
- ClinicalTrials.gov ID
- NCT06196216
- Acronym / sponsor ID
- CT chest in breast cancer
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Jan 2024 (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.
The aims of this study are To evaluate the CT features of incidental breast lesions on chest CT and subsequently suggest useful criteria for referral to a specialized breast unit.
Detailed description
Enhanced chest CT examination reports containing the key word 'breast' well be reviewed retrospectively. Patients who had incidental breast lesion and were referred to a specialized breast unit and then underwent pathological confirmation well be included. Finally, 100 patients well be enrolled. Two radiologists well evaluate lesion characteristics including; size, shape, margins and enhancement. The correlations between the CT features and pathologies well be evaluated and the diagnostic accuracy of CT features in various combinations well be assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 95 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- adult female patients who underwent enhanced CT chest that incidentally revealed breast lesion(s) then referred to a specialized breast centre and had histopathological diagnosis.
Key inclusion criteria (1 listed)
- Inclusion criteria are patients who ex hibited incidental breast lesion(s) on enhanced chest CT and were referred to a specialized breast unit for assessment and then underwent pathological confirmation.
Key exclusion criteria (3 listed)
- -Patients with known breast dis ease.
- Previous history of breast cancer or breast surgery.
- Patients who had undergone only non-enhanced CT examination.
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 |
|---|---|---|
| MSCTEnhanced CT chest | Radiation | – |
Primary outcome
detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit
Time frame: 3years
detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 25328522Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
- Background: PubMed 18180233Harish MG, Konda SD, MacMahon H, Newstead GM. Breast lesions incidentally detected with CT: what the general radiologist needs to know. Radiographics. 2007 Oct;27 Suppl 1:S37-51. doi: 10.1148/rg.27si075510.
Related trials for Breast Cancer Female
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
RecruitingObservational study
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
RecruitingPhase 2
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
Endocrine Tumors, Non-Small Cell Lung Cancer
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.
Abo-Elhassan Hassib Mohamed, Associate professor study director
Assiut University
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 Breast Cancer Female, run by Assiut 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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit (time frame: 3years). 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 NCT06196216, 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 9 Jan 2024.