Sentinel Lymph Node BiopsyNCT05703295
Oncologic Safety of Sentinel Lymph Node Biopsy in Clinically Palpable Axillary Lymph Node in Breast Cancer Patients
An observational study of Sentinel Lymph Node Biopsy, run by Assiut University.
Trial summary
Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sentinel Lymph Node Biopsy
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Mar 2025
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted to Assuit university hospitals more than 18 years old which candidate to sentinel lymph node biopsy during the time of the study.
Who may be able to join
- age more than 18 years.
- fit for surgery.
- Patients with no previous breast surgery. .
Who cannot join
- patients less than 18 years.
- patients unfit for surgery .
- patients with advanced breast cancer.
- Patients with previous breast surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oncologic Safety of Sentinel Node Biopsy in Clinically Palpable Axillary Lymph Node in Breast Cancer Patients
Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.
Read the detailed description
Breast cancer is the most common type of cancer in females and the 3rd leading cause of cancer mortality. One of the important aspects of breast cancer management is axillary staging and the status of axillary lymph nodes is an important prognosticator that affects adjuvant treatment decisions in patients with early breast carcinoma. Sentinel lymph node biopsy (SLNB), is considered to be the standard of care for node negative breast cancer, as it can save patients from the complications of axillary lymph node dissection (ALND). These complications include lymphedema, arm stiffness, and neuralgia, all of which significantly affect the patient's quality of life and raise healthcare costs. It also allows accurate axillary staging with minimal morbidity. Oncologic outcomes in terms of disease-free survival, overall survival, and locoregional recurrence rate were similar in the SLNB alone versus the ALND group in patients with clinically node-negative axilla. In doing the SLNB, a combination of radioactive technetium-99m and blue bye technique is preferred to increase the SLN identification rate than using one technique in isolation. The rationale for performing upfront SLNB as routine for patients being treated for breast cancer should be challenged, for this our study aiming for evaluation of the role of sentinel lymph node biopsy in management of breast cancer.
- Conditions
- Sentinel Lymph Node Biopsy
- Being tested
- Biopsy
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Sentinel lymph node biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncologic safety of sentinel node biopsy in clinically palpable axillary lymph node in breast cancer patients
Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (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 Sentinel Lymph Node BiopsyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibraheem Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703295
- Sponsor's protocol ID
- Sentinel lymph node biopsy
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dixon JM. Sentinel Lymph Node Biopsy in Breast Cancer Surgery. Ann Surg Oncol. 2016 Oct;23(11):3426-3428. doi: 10.1245/s10434-016-5434-6. Epub 2016 Jul 22. No abstract available.
PubMed 27448117Qiu SQ, Zhang GJ, Jansen L, de Vries J, Schroder CP, de Vries EGE, van Dam GM. Evolution in sentinel lymph node biopsy in breast cancer. Crit Rev Oncol Hematol. 2018 Mar;123:83-94. doi: 10.1016/j.critrevonc.2017.09.010. Epub 2017 Sep 20.
PubMed 29482783
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic Safety of Sentinel Node Biopsy in Clinically Palpable Axillary Lymph Node in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05703295
- Acronym / sponsor ID
- Sentinel lymph node biopsy
- Conditions
- Sentinel Lymph Node Biopsy
- Keywords
- Breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Jan 2023 (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.
Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.
Detailed description
Breast cancer is the most common type of cancer in females and the 3rd leading cause of cancer mortality. One of the important aspects of breast cancer management is axillary staging and the status of axillary lymph nodes is an important prognosticator that affects adjuvant treatment decisions in patients with early breast carcinoma. Sentinel lymph node biopsy (SLNB), is considered to be the standard of care for node negative breast cancer, as it can save patients from the complications of axillary lymph node dissection (ALND). These complications include lymphedema, arm stiffness, and neuralgia, all of which significantly affect the patient's quality of life and raise healthcare costs. It also allows accurate axillary staging with minimal morbidity. Oncologic outcomes in terms of disease-free survival, overall survival, and locoregional recurrence rate were similar in the SLNB alone versus the ALND group in patients with clinically node-negative axilla. In doing the SLNB, a combination of radioactive technetium-99m and blue bye technique is preferred to increase the SLN identification rate than using one technique in isolation. The rationale for performing upfront SLNB as routine for patients being treated for breast cancer should be challenged, for this our study aiming for evaluation of the role of sentinel lymph node biopsy in management of breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to Assuit university hospitals more than 18 years old which candidate to sentinel lymph node biopsy during the time of the study.
Key inclusion criteria (3 listed)
- age more than 18 years.
- fit for surgery.
- Patients with no previous breast surgery. .
Key exclusion criteria (4 listed)
- patients less than 18 years.
- patients unfit for surgery .
- patients with advanced breast cancer.
- Patients with previous breast surgery.
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 |
|---|---|---|
| BiopsySentinel lymph node biopsy | Procedure or surgery | – |
Primary outcome
Oncologic safety of sentinel node biopsy in clinically palpable axillary lymph node in breast cancer patients
Time frame: baseline
Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 27448117Dixon JM. Sentinel Lymph Node Biopsy in Breast Cancer Surgery. Ann Surg Oncol. 2016 Oct;23(11):3426-3428. doi: 10.1245/s10434-016-5434-6. Epub 2016 Jul 22. No abstract available.
- Background: PubMed 29482783Qiu SQ, Zhang GJ, Jansen L, de Vries J, Schroder CP, de Vries EGE, van Dam GM. Evolution in sentinel lymph node biopsy in breast cancer. Crit Rev Oncol Hematol. 2018 Mar;123:83-94. doi: 10.1016/j.critrevonc.2017.09.010. Epub 2017 Sep 20.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sentinel Lymph Node Biopsy, run by Assiut University.
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 3 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 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed Ibrahim Mohamed (01002844642 ext. 01114024156, mohammedibraheem22@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncologic safety of sentinel node biopsy in clinically palpable axillary lymph node in breast cancer patients (time frame: baseline). 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 NCT05703295, 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 30 Jan 2023.