Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation

NCT ID: NCT05568628

Last Updated: 2022-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Preganat and Lactating Faemls

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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lacating femals

screening of breast lesions in lactating female

ultrasound

Intervention Type DEVICE

screening of breast lesions by ultrasonography

pregnant

screening of breast lesions in pregnant female

ultrasound

Intervention Type DEVICE

screening of breast lesions by ultrasonography

Interventions

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ultrasound

screening of breast lesions by ultrasonography

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Hebatallah Gamal Ahmed

resident doctor at sohag cancer institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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heba G ahmed, resident doctor

Role: CONTACT

01067986223

Mohamed Z ali, professor

Role: CONTACT

01001119166

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26341843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24485752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26456897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28189388 (View on PubMed)

Other Identifiers

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Soh-Med-22-09-01

Identifier Type: -

Identifier Source: org_study_id

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