Lymph Node MetastasisNCT06401590
Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting
An observational study of Lymph Node Metastasis and Breast Cancer, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas. Sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymph Node Metastasis, Breast Cancer
- What is being tested?
- FROZEN SENTINEL LYMPH NODE BIOPSY
- How many people
- 286 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2022to 15 Apr 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who were initially diagnosed with breast cancer greater than 18 years, stage T1 to T4, N0 to N1 by Section of Histopathology, Aga Khan University Hospital, Karachi from 2021 to 2022 and subsequently received neoadjuvant chemotherapy, were included.
Who may be able to join
- Patients greater than 18 years of age
- All diagnosed breast carcinoma patients ranging from T1 to T4 and N0 to N1, who have received neoadjuvant chemotherapy will be included.
Who cannot join
- 1. Poorly preserved biopsy material, insufficient to assess all the histological features.
Trial locations and contacts
1 site in 1 country.
About this study
Axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas. Sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response. It allows to determine the axillary lymph node status, which if negative, saves the patient from axillary dissection (AD) and its potential complications. To assess tumor response to neoadjuvant chemotherapy in the SLN, pathological evaluation is the gold standard. Response to neoadjuvant systemic therapy is an excellent predictor of outcome, and achievement of pathological complete response (PCR) in the SLN is a prognostic predictor of long-term outcome with significantly better disease-free survival and overall survival. Post-treatment isolated tumor cells (ITCs) and micro metastases predict worse survival compared with the same findings in the non-neoadjuvant setting. Histologically partial response to therapy, is characterized by small clusters and individual tumor cells set in hyaline stromal fibrosis. Most false negative cases had metastatic foci identified exclusively on permanent sections and are not due to a true diagnostic interpretation error. The timing of further axillary surgery, immediate or a subsequent operation should be routinely discussed at centers using intraoperative assessment of the sentinel lymph nodes, along with the potential for negative intraoperative findings and positive nodes on final pathology.
- Conditions
- Lymph Node Metastasis, Breast Cancer
- Being tested
- FROZEN SENTINEL LYMPH NODE BIOPSY
- Medical subject headings
- Lymphatic Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FROZEN SENTINEL LYMPH NODE BIOPSYDiagnostic test
FROZEN SENTINEL LYMPH NODE BIOPSY
| Study group | Role | What they receive |
|---|---|---|
| POSITIVE CASES | Not described Receives: Diagnostic Test: FROZEN SENTINEL LYMPH NODE BIOPSY | |
| NEGATIVE CASES | Not described Receives: Diagnostic Test: FROZEN SENTINEL LYMPH NODE BIOPSY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with discrepant frozen and permanent biopsy results
The results of patient's frozen biopsy report and permanent section biopsy report will be compared and sensitivity, predictive value and false negative rate of frozen section biopsy will be assessed.
Measured: From frozen section report to permanent section biopsy report, upto 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 Mar 2022
- Primary completion15 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node MetastasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Safdar, Aga Khan University
- Investigators
- ROMANA IDRESS, MBBS, FCPS, Principal investigator, AKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401590
- Sponsor's protocol ID
- 2022-7303-20844
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic details including age, diagnosis and results including sensitivity, specificity, and false negative rate of frozen SLNB after neoadjuvant chemotherapy.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting
- ClinicalTrials.gov ID
- NCT06401590
- Acronym / sponsor ID
- 2022-7303-20844
- Conditions
- Lymph Node Metastasis, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 6 May 2024 (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.
Axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas. Sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response. It allows to determine the axillary lymph node status, which if negative, saves the patient from axillary dissection (AD) and its potential complications. To assess tumor response to neoadjuvant chemotherapy in the SLN, pathological evaluation is the gold standard. Response to neoadjuvant systemic therapy is an excellent predictor of outcome, and achievement of pathological complete response (PCR) in the SLN is a prognostic predictor of long-term outcome with significantly better disease-free survival and overall survival. Post-treatment isolated tumor cells (ITCs) and micro metastases predict worse survival compared with the same findings in the non-neoadjuvant setting. Histologically partial response to therapy, is characterized by small clusters and individual tumor cells set in hyaline stromal fibrosis. Most false negative cases had metastatic foci identified exclusively on permanent sections and are not due to a true diagnostic interpretation error. The timing of further axillary surgery, immediate or a subsequent operation should be routinely discussed at centers using intraoperative assessment of the sentinel lymph nodes, along with the potential for negative intraoperative findings and positive nodes on final pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POSITIVE CASES | – | Diagnostic Test: FROZEN SENTINEL LYMPH NODE BIOPSY |
| NEGATIVE CASES | – | Diagnostic Test: FROZEN SENTINEL LYMPH NODE BIOPSY |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who were initially diagnosed with breast cancer greater than 18 years, stage T1 to T4, N0 to N1 by Section of Histopathology, Aga Khan University Hospital, Karachi from 2021 to 2022 and subsequently received neoadjuvant chemotherapy, were included.
Key inclusion criteria (2 listed)
- Patients greater than 18 years of age
- All diagnosed breast carcinoma patients ranging from T1 to T4 and N0 to N1, who have received neoadjuvant chemotherapy will be included.
Key exclusion criteria (1 listed)
- 1. Poorly preserved biopsy material, insufficient to assess all the histological features.
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 |
|---|---|---|
| FROZEN SENTINEL LYMPH NODE BIOPSYFROZEN SENTINEL LYMPH NODE BIOPSY | Diagnostic test | NEGATIVE CASES, POSITIVE CASES |
Primary outcome
Number of patients with discrepant frozen and permanent biopsy results
Time frame: From frozen section report to permanent section biopsy report, upto 1 week.
The results of patient's frozen biopsy report and permanent section biopsy report will be compared and sensitivity, predictive value and false negative rate of frozen section biopsy will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: Yes. Demographic details including age, diagnosis and results including sensitivity, specificity, and false negative rate of frozen SLNB after neoadjuvant chemotherapy.
Related trials for Lymph Node Metastasis
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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.
ROMANA IDRESS, MBBS, FCPS principal investigator
AKU
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 Lymph Node Metastasis and Breast Cancer, run by Aga Khan University at 1 site in Pakistan.
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 1 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: finished, as of the sponsor's last update on 6 May 2024. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients with discrepant frozen and permanent biopsy results (time frame: From frozen section report to permanent section biopsy report, upto 1 week.). 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 6 May 2024.