Breast NeoplasmsNCT05214781
The Significance of Radiologically Detected Intramammary Lymph Nodes in Prediction of Axillary Lymph Nodes Status in Breast Cancer Patients
An observational study of Breast Neoplasms, run by Mansoura University at 1 site in Egypt.
Trial summary
Breast cancer is a major cause of mortality among women if not treated in early stages. Early screening and diagnosis have a lot to do with the therapeutic effect of prognosis . Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis. 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
- Breast Neoplasms
- What is being tested?
- modified radical mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Sep 2021to 4 Mar 2023
- How long will I take part?
- 6 Months
- 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: This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.
Who may be able to join
- Female patients aged more than 18 years old presented with breast cancer with radiologically detected intramammary lymph nodes and agreed to participate in the study
Who cannot join
- Pregnancy.
- Psychological instability.
- Patients who refused to participate in our study.
- Patients whose age less than 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is a major cause of mortality among women if not treated in early stages. Early screening and diagnosis have a lot to do with the therapeutic effect of prognosis .
Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis. Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis. Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis .
Read more
Intramammary lymph nodes (IMLN) are defined as a lymph nodes that should be surrounded by breast tissue in all sides, which differentiate them from those in the axillary region .
Normal IMLN are typically described in all imaging study (mammography, ultrasound and magnetic resonance imaging [MRI]) as a circumscribed mass, smaller than 10 mm, with oval shape and hilar fat, usually at a peripheral location, adjacent to a vein . The most common location (about 70%) is the upper outer quadrants, however, it may be located anywhere in the breast .
Read the detailed description
Aim of the work
- Primary outcome: prediction of axillary lymph nodes status by detection of Intramammary lymph nodes by radiological study.
- Secondary outcome: pathological correlation of molecular subtypes of breast cancer with radiological results.
Patients and Methods This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.
- Inclusion criteria included: Female patients aged more than 18 years old presented with breast cancer with radiologically detected intramammary lymph nodes and agreed to participate in the study.
- Exclusion criteria included:
- Pregnancy.
- Psychological instability.
- Patients who refused to participate in our study.
- Patients whose age less than 18 years old. * The enrolled patients will be subjected to:
1-preoperative assessment: Detailed history and clinical breast examination.
Investigations:
Laboratory :
Complete blood picture (CBC) Liver function test Kidney function test International normalized ratio (INR)
Radiology:
Bilateral breast ultrasonography. Digital mammography for patients > 40 years old. Breast Dynamic Contrast Enhanced and diffusion weighted magnetic resonance imaging.
5- Operative techniques: Modified radical mastectomy and conservative breast surgery with axillary clearance 6- Post-Operative follow up:
- Patient will stay in hospital for 1 to 2 days according to procedure and will be on antibiotic and analgesic according to hospital protocol.
- follow up amount and the color of fluid which discharge from drain.
- The wound is inspected after 48 h to be assessed.
- Histopathological examination of the specimen
- Immunohistochemistry will be done (estrogen receptor (ER) , progesterone receptor (PR) , HER-2neu and Ki-67 ) to determine the molecular subtypes of breast cancer
- We will correlate pathological data to radiological results.
- determine the post-operative type of systemic treatment according to pathological results.
- Conditions
- Breast Neoplasms
- Being tested
- modified radical mastectomy
- Keywords
- breast surgery , breast cancer , magnetic resonance image
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified radical mastectomyProcedure or surgery
Also called conservative breast surgey
excision of the whole breast tissue including nipple and skin with axillary clearance
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of axillary lymph nodes status
prediction of axillary lymph nodes status by detection of Intramammary lymph nodes by radiological study.
Measured: 6 months
Secondary outcomes (1)
pathological correlation
pathological correlation of molecular subtypes of breast cancer with radiological results.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start14 Sep 2021
- Primary completion4 Aug 2022 (estimated)
- Study completion4 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University Hospital
- Responsible party
- Principal investigator, Ayman Shemes, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214781
- Sponsor's protocol ID
- MD.21.09.521.R
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Radiologically Detected Intramammary Lymph Nodes in Prediction of Axillary Lymph Nodes Status in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05214781
- Acronym / sponsor ID
- MD.21.09.521.R
- Conditions
- Breast Neoplasms
- Keywords
- breast surgery , breast cancer , magnetic resonance image
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Mansoura University Hospital
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 4 Aug 2022 (estimated)
- Study completion
- 4 Mar 2023 (estimated)
- First posted
- 31 Jan 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.
Breast cancer is a major cause of mortality among women if not treated in early stages. Early screening and diagnosis have a lot to do with the therapeutic effect of prognosis .
Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis. Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis. Nodal status in breast cancer is one of the determining factors for staging, treatment, and prognosis .
Intramammary lymph nodes (IMLN) are defined as a lymph nodes that should be surrounded by breast tissue in all sides, which differentiate them from those in the axillary region .
Normal IMLN are typically described in all imaging study (mammography, ultrasound and magnetic resonance imaging [MRI]) as a circumscribed mass, smaller than 10 mm, with oval shape and hilar fat, usually at a peripheral location, adjacent to a vein . The most common location (about 70%) is the upper outer quadrants, however, it may be located anywhere in the breast .
Detailed description
Aim of the work
- Primary outcome: prediction of axillary lymph nodes status by detection of Intramammary lymph nodes by radiological study.
- Secondary outcome: pathological correlation of molecular subtypes of breast cancer with radiological results.
Patients and Methods This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.
- Inclusion criteria included: Female patients aged more than 18 years old presented with breast cancer with radiologically detected intramammary lymph nodes and agreed to participate in the study.
- Exclusion criteria included:
- Pregnancy.
- Psychological instability.
- Patients who refused to participate in our study.
- Patients whose age less than 18 years old. * The enrolled patients will be subjected to:
1-preoperative assessment: Detailed history and clinical breast examination.
Investigations:
Laboratory :
Complete blood picture (CBC) Liver function test Kidney function test International normalized ratio (INR)
Radiology:
Bilateral breast ultrasonography. Digital mammography for patients > 40 years old. Breast Dynamic Contrast Enhanced and diffusion weighted magnetic resonance imaging.
5- Operative techniques: Modified radical mastectomy and conservative breast surgery with axillary clearance 6- Post-Operative follow up:
- Patient will stay in hospital for 1 to 2 days according to procedure and will be on antibiotic and analgesic according to hospital protocol.
- follow up amount and the color of fluid which discharge from drain.
- The wound is inspected after 48 h to be assessed.
- Histopathological examination of the specimen
- Immunohistochemistry will be done (estrogen receptor (ER) , progesterone receptor (PR) , HER-2neu and Ki-67 ) to determine the molecular subtypes of breast cancer
- We will correlate pathological data to radiological results.
- determine the post-operative type of systemic treatment according to pathological results.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.
Key inclusion criteria (1 listed)
- Female patients aged more than 18 years old presented with breast cancer with radiologically detected intramammary lymph nodes and agreed to participate in the study
Key exclusion criteria (4 listed)
- Pregnancy.
- Psychological instability.
- Patients who refused to participate in our study.
- Patients whose age less than 18 years old.
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 |
|---|---|---|
| modified radical mastectomyAlso: conservative breast surgeyexcision of the whole breast tissue including nipple and skin with axillary clearance | Procedure or surgery | – |
Primary outcome
prediction of axillary lymph nodes status
Time frame: 6 months
prediction of axillary lymph nodes status by detection of Intramammary lymph nodes by radiological study.
1 secondary outcome
pathological correlation
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: Undecided. This is a prospective study, which will be conducted at Mansoura University Hospital from September 2021 till September 2023. This study will include thirty patients with breast cancer, after informed written consent taken from each case before being included in the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoplasms, run by Mansoura 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 4 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 14 Feb 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?
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?
prediction of axillary lymph nodes status (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2022.