Axillary assessment in breast cancer patients
| ISRCTN | ISRCTN89098304 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89098304 |
- Submission date
- 26/02/2023
- Registration date
- 14/03/2023
- Last edited
- 14/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Axillary lymph node metastasis is one of the most significant indicators of overall recurrence and long-term survival in breast cancer patients. The 5-year survival rate for individuals with breast-confined disease ranges from 90 to 99%, but it falls to 85% for those with regional lymph node metastases. Therefore, a correct evaluation of axillary lymph node status is important for staging breast cancer and choosing the best treatment. Sonography can detect metastatic lymph nodes with varying degrees of sensitivity and specificity, while its routine use in the preoperative assessment of axillary lymph nodes remains controversial. The aim of this study is to assess the diagnostic accuracy of pretreatment axillary sonography in a clinical setting in Iraq and to determine whether a sonographic evaluation of the axilla as a tool for the regional staging of breast cancer should be routinely performed in all cases.
Who can participate?
Adult women with histologically confirmed breast cancer
What does the study involve?
Axillary ultrasound (US) will be performed on all patients to assess lymph node status using certain dimensional and morphological parameters. These criteria will be recorded in the checklist designed for this study. The axillary US could be positive or negative. US will be considered positive when an abnormal node with at least one suspicious finding will be found, and US will be considered negative when there are non-visualized or non-suspicious nodes. US-guided fine-needle aspiration biopsy will be done on all patients with positive axillary US results. Patients with negative axillary US results will have a sentinel lymph node biopsy. The US findings will be compared to the histopathology results.
What are the possible benefits and risks of participating?
The study benefits the participants in deciding on further management. There is no risk from a US examination and the risk of biopsy taking can be reduced by performing the procedure by expert doctors at the hospital.
Where is the study run from?
Rizgary Teaching Hospital and the Department of Surgery, College of Medicine, Hawler Medical University (Iraq)
When is the study starting and how long is it expected to run for?
August 2021 to January 2023
Who is funding the study?
Hawler Medical University (Iraq)
Who is the main contact?
Dr Shawnam Nasih Dawood, shawnm.nasih@hmu.edu.krd (Iraq)
Contact information
Principal Investigator
Erbil
Erbil
44001
Iraq
 ORCID ID |
0000-0001-8826-3865 |
|---|---|
| Phone | +9647504701688 |
| shawnm.nasih@hmu.edu.krd |
Scientific
Erbil
Erbil
44001
Iraq
| Phone | +9647504701688 |
|---|---|
| shawnm.nasih@hmu.edu.krd |
Public
Erbil
Erbil
44001
Iraq
| ORCID ID |
0000-0002-2257-2566 |
|---|---|
| Phone | + 9647503875555 |
| aska.faruq@hmu.edu.krd |
Study information
| Study design | Prospective diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Sonographic evaluation of axillary lymph node status in newly diagnosed breast cancer patients: A prospective study |
| Study objectives | Sonography can detect metastatic lymph nodes with varying degrees of sensitivity and specificity, while its routine use in the preoperative assessment of axillary lymph nodes remains controversial. |
| Ethics approval(s) | Approved 01/09/2021, Research Ethics Committee of The College of Medicine / Hawler Medical University (College of Medicine, Khanzad Street, Erbil, Kurdistan Region, Iraq; +964 66 222 7275; medicine@hmu.edu.krd), ref: none available |
| Health condition(s) or problem(s) studied | Axillary assessment in breast cancer patients |
| Intervention | Accuracy of axillary ultrasound (US) in diagnosing metastatic lymph nodes in breast cancer patients US will be performed on breast cancer patients to assess lymph node status using predetermined criteria, which include the presence of any breast lesion and its features, location, and dimensions. Correct evaluation of axillary lymph node status is important for staging breast cancer and choosing the best treatment, sonography is an easy non-invasive, cost-effective method to assess the axillary lymph nodes. The study participants are women with histologically confirmed breast cancer. Procedures: Following a hand-held whole-breast US examination, axillary US is performed using linear 7–12 MHz transducers. The procedure is explained to the patients, and a nurse will position the patients. Both breasts are examined in orthogonal planes, and the presence of any breast lesion and its features, location, and dimensions are documented. The scanning of the axilla starts from the lowest part and continued upward toward the axillary fossa. Both axillae are examined for the presence of nodes and the features of any detected nodes, such as level, number, size, overall shape, margin, assessment of the cortex and hilum, and lymph node vascularity. The following lymph node criteria are regarded as suspicious: round or irregular shape; lobulated or irregular margin; cortical changes, such as diffuse cortical thickness ≥ 3 mm, focal cortical thickness ≥ 3 mm, or markedly hypoechoic cortex; and sinus changes, such as displacement or total replacement, in addition to nonhilar blood flow displayed by color Doppler sonography. Then, these dimensional and morphological criteria are recorded. The axillary US could be positive or negative. US is considered positive when an abnormal node with at least one suspicious finding is found, and US is considered negative in cases of nonvisualized or nonsuspicious nodes. US-guided fine needle aspiration biopsy (FNAB) is done on all patients with positive axillary US results. Under completely aseptic conditions, a local anesthetic (lidocaine) is applied to the skin. The dominant lymph node is identified under US guidance, and then aspiration is achieved by capillarity using a 23- or 25-gauge needle and a 5-cc syringe. Enough aspirates are obtained to prepare two slides, which then had fixed with 95.6% ethanol, the specimen then sent for cytological examination. Expert breast radiologists with more than five years in breast imaging and fellowship in breast radiology performed the US examination and the US-guided FNAB. Face-to-face intervention and each patient will be examined alone in the presence of a nurse and a radiologist. All the procedures took place at the hospital. The US examination is performed only once, took only a few minutes, and caused no discomfort to the patient, except for exposing the axillary region to the cold, which is ameliorated by a proper room temperature. Additionally, the gel used for the examination could be easily removed by napkins. Patients with negative FNAB and axillary ultrasound results had a sentinel lymph node biopsy (SLNB). As standard care for breast cancer patients, SLNB is performed by specialist breast surgeons on the day of the operation. Patients with metastatic lymph nodes on frozen sections routinely underwent immediate axillary surgery during the study period, with no further axillary interference for sentinel lymph node-negative patients. Modifications: The procedure went according to the protocol. Planned: All US examinations are real-time and the performing radiologist can adjust the examination during the procedure. Patient data, including age; tumor characteristics, such as tumor size, location, type, grade, and focality; sonographic axillary status; and pathology findings are reviewed and analyzed. The diagnostic accuracy of preoperative axillary US and the performance of US criteria for diagnosing metastatic lymph nodes are studied. IBM SPSS Statistics, Version 25.0, is used for all statistical analyses (IBM Corp.). P values less than 0.05 are considered statistically significant. |
| Intervention type | Other |
| Primary outcome measure | Evidence of any breast lesion and its features, location, and dimensions measured using ultrasound versus histopathology at one timepoint |
| Secondary outcome measures | Accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of diagnosing metastatic lymph nodes measured using axillary ultrasound at one timepoint |
| Overall study start date | 22/08/2021 |
| Completion date | 01/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 180 |
| Key inclusion criteria | Women with histologically confirmed breast cancer |
| Key exclusion criteria | 1. A prior diagnosis of breast cancer who had undergone any type of neoadjuvant treatment or surgical procedure 2. Breast cancer patients planned for neoadjuvant chemotherapy 3. History of lymphoma or other malignancies 4. Pregnancy or breastfeeding |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 01/12/2022 |
Locations
Countries of recruitment
- Iraq
Study participating centres
Erbil
44001
Iraq
Erbil
44001
Iraq
Sponsor information
University/education
Erbil
Erbil
44001
Iraq
| Phone | +964 66 2273384 |
|---|---|
| info@hmu.edu.krd | |
| Website | http://hmu.edu.krd/ |
"ROR" |
https://ror.org/02a6g3h39 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an open-access peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from the author: Dr Shawnam Nasih Dawood, shawnm.nasih@hmu.edu.krd The type of data that will be shared: All of the individual participant’s data collected during the trial, after deidentification. Timing for availability: Immediately following publication. No end date. Whether consent from participants was required and obtained: Participant consent was required and obtained Comments on data anonymization: No names, photos or any other personal information were included Any ethical or legal restrictions: Not applicable Any additional comments: Please note that this study is part of the trialist's ongoing PhD requirements and the cases were selected from the thesis under the title of Mammography, Sonography, and Magnetic Resonance Imaging in Breast Cancer Disease: A Comparative Study |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | 20/02/2023 | 14/11/2023 | No | No |
Editorial Notes
14/11/2023: The following changes have been made:
1. The secondary study design has been changed from 'cross-sectional study' to 'cohort study'.
2. The final enrolment number has been changed from 185 to 180.
3. The publication and dissemination plan has been changed from "Planned publication in a high-impact peer-reviewed journal" to "Planned publication in an open-acess peer-reviewed journal".
4. The intention to publish date has been changed from 01/06/2023 to 01/11/2023.
5. Preprint reference added.
03/05/2023: The intention to publish date was changed from 01/05/2023 to 01/06/2023.
14/03/2023: Trial's existence confirmed by Hawler Medical University College of Medicine research ethics committee.
