This section has been designed to provide Trusts wishing to progress with implementation of the technology with the evidence base required to agree business cases and ensure that the technology being adopted is safe and complies with relevant clinical governance frameworks locally and nationally.
In this section you will find a short background to national standards, relevant trial reports & supporting evidence, other useful reference papers, testimonials from the Trusts involved in the implemenetation project and other useful websites.
Methods of quantitative and qualitative measurement and evaluation of the clinical utility of implementing the intra-operative test were developed by project teams from the NTAC project implementation and mentor sites. These were used in the determination of the impact of the technology on patient outcomes and support requirements, hospital resource requirements and the clinical utility of adoption the technology.
The evaluation measures and values were subjected to independent analysis undertaken by the NHS Technology Adoption Centre and York Health Economics Consortium. The data was further reviewed by the NHS Information Centre for Health and Social Care.
- Click here to access summary data presentation in a pdf file.
- Click here to access the headline project data report in a pdf file.
- Click here to access the full project data report in a pdf file.
- Click here to access the economic analysis report in a pdf file.
Current practice for breast cancer treatments see permanent section histological examinations (H&E) performed by a Histopathologist, which is considered the 'gold standard' test method for Breast Lymph Node Analysis (conventional sentinel node histology). Very few centres in the UK perform intraoperative testing of the sentinel lymph nodes.
- Permanent Section H&E however is not standardised, the actual tissue viewed is 2-10% of the total lymph node and there is the potential to miss 10-15% of clinically relevant metastases (>0.2mm). Intra-operative histology-frozen section and touch preparation has a rapid turnaround time, however, it samples less of node than permanent section, lacks sensitivity (50-85% according to well researched and proven literature), is not standardised and requires specialised skills.
- Since there is no fast method for high quality lymph node assessment available, current histology-based sentinel lymph node protocols are adhered to, which requires a second surgical procedure once the node is found to be tumour positive.
NICE guidance for Early and Locally Advanced Breast Cancer (2009) advocates that minimal surgery, rather than lymph node clearance, should be performed to stage the axilla for patients with early invasive breast cancer. The intra-operative analysis of sentinel lymph nodes offers the opportunity to streamline the management of breast cancer patients as part of a cohesive and comprehensive service, and an article in the journal of Histopathology (July 2009) concluded that this test is accepted as a reliable technique.
Douglas-Jones AG, Woods V
Molecular Assessment of sentinel lymph node in breast cancer management, Histopathology, Volume 55, Number 1, July 2009
View this article here: http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2559.2008.03218.x/full
NICE quick reference guide, Early and Locally Advanced Breast Cancer, 2009
View this guidance here: http://www.nice.org.uk/nicemedia/pdf/CG80NICEGuideline.pdf
Sentinel node biopsy in breast cancer: ALMANAC trial
View the abstract for this article here: http://www.ncbi.nlm.nih.gov/pubmed/11376421
Intraoperative assessment of sentinel lymph nodes: no frozen section required
View the abstract for this article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2443144/
Observational and cost analysis of the implementation of breast cancer sentinel node intraoperative molecular diagnosis (2010)
View abstract for this article here: http://jcp.bmj.com/content/63/6/522.abstract
Intra-operative rapid diagnostic method based on CK19 mRNA expression for the detection of lymph node metastases in breast cancer
View abstract for this article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2658031/
Identification of Mammaglobin as a Novel Serum Marker for Breast Cancer, Clinical Cancer Research, 11(18), 6528-6535
To view this article click here: http://clincancerres.aacrjournals.org/content/11/18/6528.full.pdf
Sentinel lymph node biopsy versus axillary clearance in operable breast cancer: The RACS SNAC trial, a multicentre randomized trial of Royal Australian College of Surgeons (RACS) Section of Breast Surgery, in collaboration with the National Health and Medical Research Council Trials Center', Annals of Surgical Oncology, 11(3 Suppl), 216S-221S
To view abstract for this article click here: http://www.ncbi.nlm.nih.gov/pubmed/15023755
Comparison of morbidity between axillary lymph node dissection and sentinel node biopsy, European Journal of Surgical Oncology, 29(4), 341-350
To view abstract for this article click here: http://www.sciencedirect.com/science/article/pii/S0748798302913855
Participation in the RACS sentinel node biopsy versus axillary clearance trial, ANZ Journal of Surgery, 75(3), 98-100.
To view abstract for this article click here: http://espace.library.uq.edu.au/view/UQ:76929
Mammaglobin: a candidate diagnostic marker for breast cancer, Clinical Biochemistry, 37(4), 249-257.
To view abstract for this article click here: http://www.sciencedirect.com/science/article/pii/S0009912003002236
Mammaglobin Expression in Primary, Metastatic and Occult Breast Cancer, Cancer Research 59, 3028-3031
To view article for this publication click here: http://cancerres.aacrjournals.org/content/59/13/3028.full.pdf
Rapid intra operative detection of lymph node metastases in breast cancer using a new molecular diagnostic method.
To view article for this publication click here: http://onlinelibrary.wiley.com/doi/10.1002/bjs.7229/pdf
One-step Nucleic Acid Amplification for Intraoperative Detection of Lymph NodeMetastasis in Breast Cancer Patients
To view this article click here: http://clincancerres.aacrjournals.org/content/13/16/4807.full
Eighteen months clinical experience with the GeneSearch breast lymph node assay
To view abstract for this article click here: http://www.sciencedirect.com/science/article/pii/S0002961008008246
A Joint Document Incorporating the Third Edition of the NHS Breast Cancer Screening Programme's Guidelines for Pathology Reporting in Breast Cancer Screening.
To view this publication click here: http://www.cancerscreening.nhs.uk/breastscreen/publications/nhsbsp58-low-resolution.pdf
Department of Health
Chemotherapy Services in England: Ensuring quality and safety, 2010.
To view this report click here: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/DH_104500
Guide to practice-based commissioners in developing good cancer care services, June 2009.
To view this guide click here: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_101177
Cancer Reform Strategy - 2010
To view this strategy click here: http://www.cancer.nhs.uk/chemotherapy/documents/CRS%20-%202%20years%20on.pdf
National Cancer Intelligence Network
November 2009: Report and Presentations from the NCIN Co-morbidity Data Collection Workshop.
Transforming Care for Cancer Inpatients - Spreading the Winning Principles and Good Practice, July 2009
Click here to view this publication
Ensuring Better Treatment: Going Further on Cancer Waits - An Improvement guide for supporting sustainable delivery, February 2009.
Click here to view this guide
Locally Developed CQUIN Schemes 2009/10
Measuring Surgical Outcomes
Delivering the 18 week Patient Pathway
Observational and cost analysis of the implementation of breast cancer sentinel node and intra operative molecular diagnosis.
Intra-operative sentinel node Metastasis detection in breast cancer by One-Step Nucleic Acid Amplification 'OSNA': Results of the French multi-centric study. Congres Milan, 02-06-2008.
Click here to view this poster
OSNA (One Step Nucleic Acid Amplification) as a diagnostic tool for the detection of Lymph node metastasis in breast cancer patients: from post-operative performance evaluation in intra-operative use.
Click here to view this poster
Intra-operative detection of sentinel lymph node metastasis in breast cancer by One-Step Nucleic Acid Amplification (OSNA): results of 288 Sentinel lymph nodes from IRE-Roma. A Clinical Change.
Click here to view this poster
OSNA reference from Japan
OSNA reference from the Dutch study
OSNA reference from the German study
OSNA reference from the second Japan study
Article from Biomedical Scientist outlining the practicalities of introducing the test
The Time article (2009) http://www.timesonline.co.uk/tol/life_and_style/health/article6897567.ece
Neither the NHS Technology Adoption Centre (NTAC) nor its contributors are responsible for the contents of any off-site pages referenced. The user specifically acknowledges that neither NTAC nor its contributors is liable for the defamatory, offensive, or illegal conduct of other users, links, or third parties and that the risk of injury from the foregoing rests entirely with the user.
Links from the NTAC How to Why to Guides site on the World Wide Web to other sites do not constitute any endorsement. These links are provided as an information service only. It is the responsibility to the web surfer to evaluate the content and usefulness of information obtained from other sites.
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