Breast NeoplasmsNCT07591506
Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer
A study testing Intraoperative Frozen Section Examination of Sentinel Lymph Node and Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node in people with Breast Neoplasms, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized clinical study evaluates the role of intraoperative frozen section examination of sentinel lymph nodes in patients with breast cancer. The study aims to determine whether frozen section assessment during surgery improves intraoperative decision-making and affects surgical management when… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Intraoperative Frozen Section Examination of Sentinel Lymph Node and Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with breast carcinoma
- No prior neoadjuvant treatment
Who cannot join
- Inability to localize the sentinel lymph node preoperatively by lymphoscintigraphy or blue dye
- Previous axillary surgery
- Recurrent breast cancer
- Patients who cannot receive radiotherapy
- Prior neoadjuvant treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer: A Prospective Randomized Clinical Study
This prospective randomized clinical study evaluates the role of intraoperative frozen section examination of sentinel lymph nodes in patients with breast cancer. The study aims to determine whether frozen section assessment during surgery improves intraoperative decision-making and affects surgical management when compared with standard final pathological evaluation performed after surgery.
- Conditions
- Breast Neoplasms
- Being tested
- Intraoperative Frozen Section Examination of Sentinel Lymph Node, Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node
- Keywords
- sentinel lymph node biopsy, frozen section, breast cancer, intraoperative pathology, axillary staging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Frozen Section Examination of Sentinel Lymph NodeDiagnostic test
Sentinel lymph nodes are rapidly transported to pathology without formaldehyde fixation and are evaluated intraoperatively by frozen section.
Routine Postoperative Histopathological Evaluation of Sentinel Lymph NodeDiagnostic test
Sentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Frozen Section Group | Experimental | Participants undergo sentinel lymph node biopsy with intraoperative frozen section examination. Sentinel lymph nodes are identified using blue dye and a gamma probe, and intraoperative decision-making regarding additional axillary intervention is based on frozen section results. Receives: Diagnostic Test: Intraoperative Frozen Section Examination of Sentinel Lymph Node |
| Routine Histopathology Group | Active comparator | Participants undergo sentinel lymph node biopsy without intraoperative frozen section. Sentinel lymph nodes are identified using blue dye and a gamma probe, then processed after formaldehyde fixation with routine histopathological evaluation. Further axillary treatment is decided according to final pathology and tumor board assessment. Receives: Diagnostic Test: Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants randomized to the frozen section group and the routine histopathology group
Count of participants randomized by sealed-envelope method to either intraoperative frozen section evaluation of sentinel lymph nodes or routine histopathological evaluation after formalin fixation. This outcome will be reported as the total number of randomized participants until the protocol-defined target sample size for between-group comparison is reached (planned total sample size: 142 participants).
Measured: From first participant enrollment until the target sample size is reached, up to 1 year
Secondary outcomes (1)
Percentage of participants in the routine histopathology group who require axillary lymph node dissection
Percentage of participants assigned to the routine histopathology group without intraoperative frozen section who require axillary lymph node dissection based on final histopathological evaluation and multidisciplinary treatment decision.
Measured: From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Orhan Ureyen, Prof. / MD, Principal investigator, Izmir City Hospital / General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591506
- Sponsor's protocol ID
- Breast
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer: A Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07591506
- Acronym / sponsor ID
- Breast
- Conditions
- Breast Neoplasms
- Keywords
- sentinel lymph node biopsy, frozen section, breast cancer, intraoperative pathology, axillary staging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 15 May 2026 (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.
This prospective randomized clinical study evaluates the role of intraoperative frozen section examination of sentinel lymph nodes in patients with breast cancer. The study aims to determine whether frozen section assessment during surgery improves intraoperative decision-making and affects surgical management when compared with standard final pathological evaluation performed after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frozen Section Group | Experimental | Diagnostic Test: Intraoperative Frozen Section Examination of Sentinel Lymph NodeParticipants undergo sentinel lymph node biopsy with intraoperative frozen section examination. Sentinel lymph nodes are identified using blue dye and a gamma probe, and intraoperative decision-making regarding additional axillary intervention is based on frozen section results. |
| Routine Histopathology Group | Active comparator | Diagnostic Test: Routine Postoperative Histopathological Evaluation of Sentinel Lymph NodeParticipants undergo sentinel lymph node biopsy without intraoperative frozen section. Sentinel lymph nodes are identified using blue dye and a gamma probe, then processed after formaldehyde fixation with routine histopathological evaluation. Further axillary treatment is decided according to final pathology and tumor board assessment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with breast carcinoma
- No prior neoadjuvant treatment
Key exclusion criteria (5 listed)
- Inability to localize the sentinel lymph node preoperatively by lymphoscintigraphy or blue dye
- Previous axillary surgery
- Recurrent breast cancer
- Patients who cannot receive radiotherapy
- Prior neoadjuvant treatment
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 |
|---|---|---|
| Intraoperative Frozen Section Examination of Sentinel Lymph NodeSentinel lymph nodes are rapidly transported to pathology without formaldehyde fixation and are evaluated intraoperatively by frozen section. | Diagnostic test | Frozen Section Group |
| Routine Postoperative Histopathological Evaluation of Sentinel Lymph NodeSentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery. | Diagnostic test | Routine Histopathology Group |
Primary outcome
Number of participants randomized to the frozen section group and the routine histopathology group
Time frame: From first participant enrollment until the target sample size is reached, up to 1 year
Count of participants randomized by sealed-envelope method to either intraoperative frozen section evaluation of sentinel lymph nodes or routine histopathological evaluation after formalin fixation. This outcome will be reported as the total number of randomized participants until the protocol-defined target sample size for between-group comparison is reached (planned total sample size: 142 participants).
1 secondary outcome
Percentage of participants in the routine histopathology group who require axillary lymph node dissection
Time frame: From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Orhan Ureyen, Prof. / MD principal investigator
Izmir City Hospital / General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Frozen Section Examination of Sentinel Lymph Node and Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node in people with Breast Neoplasms, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants randomized to the frozen section group and the routine histopathology group (time frame: From first participant enrollment until the target sample size is reached, up to 1 year). 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 15 May 2026.