Preganat and Lactating FaemlsNCT05568628
Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation
An observational study of Preganat and Lactating Faemls, run by Sohag University at 1 site in Egypt.
Trial summary
All breast disorders found during pregnancy and lactation should be carefully evaluated. Most of them are benign e.g., lactating adenoma, galactocele, fibroadenoma or inflammatory disorders e.g., mastitis, abscess formation, granulomatous mastitis, but it is essential to exclude pregnancy-associated breast cancer… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preganat and Lactating Faemls
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2022to Jun 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Pregnant and lactating women with or without complaining of breast pain or breast lump referred from Obstetric and Gynecological outpatient clinic or surgery outpatient clinic
Who may be able to join
- Pregnant and lactating women with or without complaining of breast pain or breast lump referred from Obstetric and Gynecological outpatient clinic or surgery outpatient clinic
Who cannot join
- Non pregnant, non-lactating females, females with previous breast surgery or breast mass lesions before pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Mohamed Z ali, professor contact
About this study
All breast disorders found during pregnancy and lactation should be carefully evaluated. Most of them are benign e.g., lactating adenoma, galactocele, fibroadenoma or inflammatory disorders e.g., mastitis, abscess formation, granulomatous mastitis, but it is essential to exclude pregnancy-associated breast cancer (PABC), which is too often diagnosed late Ultrasound is the first line breast imaging technique during pregnancy and lactation as Development of alveoli during pregnancy might not occur symmetrically, and these can be felt as focal nodularities, or even feel similar to masses, any suspicion of a mass should be assessed with US . If US illustrates glandular tissue and this correlates with the examiner presumption, no further work-up needs to be done. However, if presence of a mass is highly assumed, further follow-up by mammography, MRI and biopsy, when necessary, must be performed
- Conditions
- Preganat and Lactating Faemls
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
screening of breast lesions by ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| lacating femals | screening of breast lesions in lactating female Receives: Device: ultrasound | |
| pregnant | screening of breast lesions in pregnant female Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of breast lesions in pregnant and lactating females'
percent of breast lesions in pregnant and lactating females'
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 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 Preganat and Lactating FaemlsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Gamal Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568628
- Sponsor's protocol ID
- Soh-Med-22-09-01
- Status last verified
- Oct 2022
- First submitted
- 2 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Langer A, Mohallem M, Berment H, Ferreira F, Gog A, Khalifa D, Nekka I, Cherel P. Breast lumps in pregnant women. Diagn Interv Imaging. 2015 Oct;96(10):1077-87. doi: 10.1016/j.diii.2015.07.005. Epub 2015 Sep 2.
PubMed 26341843Langer A, Mohallem M, Stevens D, Rouzier R, Lerebours F, Cherel P. A single-institution study of 117 pregnancy-associated breast cancers (PABC): Presentation, imaging, clinicopathological data and outcome. Diagn Interv Imaging. 2014 Apr;95(4):435-41. doi: 10.1016/j.diii.2013.12.021. Epub 2014 Jan 31.
PubMed 24485752Genin AS, De Rycke Y, Stevens D, Donnadieu A, Langer A, Rouzier R, Lerebours F. Association with pregnancy increases the risk of local recurrence but does not impact overall survival in breast cancer: A case-control study of 87 cases. Breast. 2016 Dec;30:222-227. doi: 10.1016/j.breast.2015.09.006. Epub 2015 Oct 9.
PubMed 26456897Parker S, Saettele M, Morgan M, Stein M, Winkler N. Spectrum of Pregnancy- and Lactation-related Benign Breast Findings. Curr Probl Diagn Radiol. 2017 Nov-Dec;46(6):432-440. doi: 10.1067/j.cpradiol.2016.12.013. Epub 2016 Dec 27.
PubMed 28189388
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation
- ClinicalTrials.gov ID
- NCT05568628
- Acronym / sponsor ID
- Soh-Med-22-09-01
- Conditions
- Preganat and Lactating Faemls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 5 Oct 2022 (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.
All breast disorders found during pregnancy and lactation should be carefully evaluated. Most of them are benign e.g., lactating adenoma, galactocele, fibroadenoma or inflammatory disorders e.g., mastitis, abscess formation, granulomatous mastitis, but it is essential to exclude pregnancy-associated breast cancer (PABC), which is too often diagnosed late Ultrasound is the first line breast imaging technique during pregnancy and lactation as Development of alveoli during pregnancy might not occur symmetrically, and these can be felt as focal nodularities, or even feel similar to masses, any suspicion of a mass should be assessed with US . If US illustrates glandular tissue and this correlates with the examiner presumption, no further work-up needs to be done. However, if presence of a mass is highly assumed, further follow-up by mammography, MRI and biopsy, when necessary, must be performed
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lacating femals | – | Device: ultrasoundscreening of breast lesions in lactating female |
| pregnant | – | Device: ultrasoundscreening of breast lesions in pregnant female |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Pregnant and lactating women with or without complaining of breast pain or breast lump referred from Obstetric and Gynecological outpatient clinic or surgery outpatient clinic
Key inclusion criteria (1 listed)
- Pregnant and lactating women with or without complaining of breast pain or breast lump referred from Obstetric and Gynecological outpatient clinic or surgery outpatient clinic
Key exclusion criteria (1 listed)
- Non pregnant, non-lactating females, females with previous breast surgery or breast mass lesions before pregnancy or lactation.
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 |
|---|---|---|
| ultrasoundscreening of breast lesions by ultrasonography | Device | lacating femals, pregnant |
Primary outcome
percent of breast lesions in pregnant and lactating females'
Time frame: 12 month
percent of breast lesions in pregnant and lactating females'
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 26341843Langer A, Mohallem M, Berment H, Ferreira F, Gog A, Khalifa D, Nekka I, Cherel P. Breast lumps in pregnant women. Diagn Interv Imaging. 2015 Oct;96(10):1077-87. doi: 10.1016/j.diii.2015.07.005. Epub 2015 Sep 2.
- Background: PubMed 24485752Langer A, Mohallem M, Stevens D, Rouzier R, Lerebours F, Cherel P. A single-institution study of 117 pregnancy-associated breast cancers (PABC): Presentation, imaging, clinicopathological data and outcome. Diagn Interv Imaging. 2014 Apr;95(4):435-41. doi: 10.1016/j.diii.2013.12.021. Epub 2014 Jan 31.
- Background: PubMed 26456897Genin AS, De Rycke Y, Stevens D, Donnadieu A, Langer A, Rouzier R, Lerebours F. Association with pregnancy increases the risk of local recurrence but does not impact overall survival in breast cancer: A case-control study of 87 cases. Breast. 2016 Dec;30:222-227. doi: 10.1016/j.breast.2015.09.006. Epub 2015 Oct 9.
- Background: PubMed 28189388Parker S, Saettele M, Morgan M, Stein M, Winkler N. Spectrum of Pregnancy- and Lactation-related Benign Breast Findings. Curr Probl Diagn Radiol. 2017 Nov-Dec;46(6):432-440. doi: 10.1067/j.cpradiol.2016.12.013. Epub 2016 Dec 27.
- Individual participant dataSharing planned: Undecided
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.
Mohamed Z ali, professor contact
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 Preganat and Lactating Faemls, 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 6 Oct 2022. 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 heba G ahmed, resident doctor (01067986223, hebatallah_07649@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent of breast lesions in pregnant and lactating females' (time frame: 12 month). 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 NCT05568628, 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 6 Oct 2022.