Clinical trial NCT05568628: Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation
Official title: Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preganat and Lactating Faemls
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 (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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Non pregnant, non-lactating females, females with previous breast surgery or breast mass lesions before pregnancy or lactation.

Primary outcomes:
measure: percent of breast lesions in pregnant and lactating females'
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: Langer 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.
citation: Genin 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.
citation: Parker 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.