Tests to assist in the staging of cutaneous melanoma: a generic protocol
Información
- DOI:
- https://doi.org/10.1002/14651858.CD012806Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 25 septiembre 2017see what's new
- Tipo:
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- Diagnostic
- Etapa:
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- Protocol
- Grupo Editorial Cochrane:
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Grupo Cochrane de Piel
- Copyright:
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- Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Autores
Contributions of authors
JDi was the contact person with the editorial base.
JDi co‐ordinated the contributions from the co‐authors and wrote the final draft of the protocol.
JDi, CD, NC, JDe, YT, SB worked on the Methods sections.
JDi, DS, STC, RM, HW drafted the clinical sections of the Background and responded to the clinical comments of the referees.
JDi, JJD, YT, CD responded to the methodology and statistics comments of the referees.
JDi, HW, RM, CD, NC, JDe, YT, SB, DS, STC contributed to writing the protocol.
KG was the consumer co‐author and checked the protocol for readability and clarity. She also ensured that the outcomes are relevant to consumers.
JDi is the guarantor of the final review.
Disclaimer
This project is supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure funding to the Cochrane Skin Group and Cochrane Programme Grant funding. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, National Health Service (NHS) or the Department of Health.
Sources of support
Internal sources
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No sources of support supplied
External sources
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NIHR Systematic Review Programme, UK.
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National Institute for Health Research (NIHR), UK.
The NIHR, UK, is the largest single funder of the Cochrane Skin Group
Declarations of interest
Jacqueline Dinnes: nothing to declare.
Daniel Saleh: nothing to declare.
Julia Newton‐Bishop: she has undertaken legal work, offering advice on patient complaint issues, paid for by patients. Her research group, the Leeds Institute of Cancer & Pathology (LICP) Melanoma Research Group (MRG), is in receipt of a number of research grants from Cancer Research UK, the Medical Research Council, the National Institutes of Health, and the Melanoma Research Alliance. She received a single honorarium from conference organisers for a talk given at an academic meeting in Bergen, which she paid into the MRG research account. None of the entities listed are commercial sponsors.
Seau Tak Cheung: nothing to declare.
Paul Nathan: he has received consultancy fees from Bristol Myers Squibb (BMS), Pfizer, Merck Sharp Dohme (MSD), Merck, and Immunocore to sit on advisory boards. He has received payment from BMS and Novartis for lectures at satellite symposia; payment from BMS for webcasts; payment of travel, accommodations, and meeting expenses from BMS and MSD for attending conferences of the American Society of Clinical Oncology, Society for Melanoma Research, and European Society of Medical Oncology.
Rubeta N Matin: nothing to declare.
Naomi Chuchu: nothing to declare.
Susan E Bayliss: nothing to declare.
Yemisi Takwoingi: nothing to declare.
Clare Davenport: nothing to declare.
Kathie Godfrey: nothing to declare.
Colette O'Sullivan: nothing to declare.
Jonathan J Deeks: nothing to declare.
Hywel C Williams: nothing to declare.
Acknowledgements
The Cochrane Skin editorial base wishes to thank Luigi Naldi, the key Editor for this protocol; Brian Stafford, the consumer referee; and the clinical referees, An‐Wen Chan and Chante Karimkhani. We also thank Clare Dooley, the copy‐editor of this protocol.
We also wish to thank the Cochrane DTA editorial base and colleagues.
Version history
| Published | Title | Stage | Authors | Version |
| 2019 Jul 01 | Ultrasound, CT, MRI, or PET‐CT for staging and re‐staging of adults with cutaneous melanoma | Review | Jacqueline Dinnes, Lavinia Ferrante di Ruffano, Yemisi Takwoingi, Seau Tak Cheung, Paul Nathan, Rubeta N Matin, Naomi Chuchu, Sue Ann Chan, Alana Durack, Susan E Bayliss, Abha Gulati, Lopa Patel, Clare Davenport, Kathie Godfrey, Manil Subesinghe, Zoe Traill, Jonathan J Deeks, Hywel C Williams, Cochrane Skin Cancer Diagnostic Test Accuracy Group | |
| 2017 Sep 25 | Tests to assist in the staging of cutaneous melanoma: a generic protocol | Protocol | Jacqueline Dinnes, Daniel Saleh, Julia Newton‐Bishop, Seau Tak Cheung, Paul Nathan, Rubeta N Matin, Naomi Chuchu, Susan E Bayliss, Yemisi Takwoingi, Clare Davenport, Kathie Godfrey, Colette O'Sullivan, Jonathan J Deeks, Hywel C Williams | |
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Diagnosis, Computer-Assisted [methods];
- Magnetic Resonance Imaging;
- Melanoma [*diagnostic imaging];
- Melanoma, Cutaneous Malignant;
- *Neoplasm Metastasis;
- Neoplasm Recurrence, Local [diagnostic imaging];
- *Neoplasm Staging;
- Positron Emission Tomography Computed Tomography;
- Randomized Controlled Trials as Topic;
- Sensitivity and Specificity;
- Skin Neoplasms [*diagnostic imaging];
- Tomography, X-Ray Computed;
- Ultrasonography;
Medical Subject Headings Check Words
Adult; Humans;
Summary of NICE guideline recommendations for the management of cutaneous melanoma following primary diagnosis (NICE guidance 2015)
| Term | Definition |
| Adjuvant therapy or treatment | A treatment given after the main treatment for cancer to reduce the risk of recurrence. |
| Adverse event | Detrimental change in health occurring in a person receiving the treatment whether or not it has been caused by the treatment. |
| Axillary | In the armpit. |
| Biopsy | Removal of a sample of tissue from the body to assist in diagnosis or inform the choice of treatment of a disease. |
| BRAF V600 mutation | BRAF is a human gene that makes a protein called B‐Raf which is involved in the control of cell growth. BRAF mutations (damaged DNA) occur in around 40% of melanomas, which can then be treated with particular drugs. |
| BRAF inhibitors | Therapeutic agents which inhibit the serine‐threonine protein kinase BRAF mutated metastatic melanoma. |
| Breslow thickness | A scale for measuring the thickness of melanomas by the pathologist using a microscope, measured in mm from the top layer of skin to the bottom of the tumour. |
| Cervical (lymph nodes) | Lymph nodes found in the neck area of the body. |
| Computed tomography (CT) | Imaging technique in which the person lies on a table within an x‐ray gantry. The images are acquired using a spiral (helical) path and banks of detectors, allowing presentation of the internal organs and blood vessels in different projections including 3‐D views. |
| Coronal | Frontal plane dividing the body into front and back. |
| False negative | An individual who is truly positive for a disease, but whom a diagnostic test classifies them as disease‐free. |
| False positive | An individual who is truly disease‐free, but whom a diagnostic test classifies them as having the disease. |
| Histopathology | The study of tissue, usually obtained by biopsy or excision, for example under a microscope. |
| Incidence | The number of new cases of a disease in a given time period. |
| Inguinal | Lymph nodes in or just above or just below the groin. |
| Isolated limb perfusion | A medical procedure that directly delivers a drug through the bloodstream in a limb to the site affected by melanoma. |
| Local recurrence | Regrowth of a tumour in the area from which it was originally removed. |
| Locoregional recurrence | Regrowth of a tumour in the area from which it was originally removed or in the regional lymph nodes (usually nearest to the original tumour site). |
| Lymph node | Lymph nodes filter the lymphatic fluid (clear fluid containing white blood cells) that travels around the body to help fight disease; they are located throughout the body often in clusters (nodal basins). |
| Lymph node dissection | Surgical removal or one or more lymph nodes in the absence of proven involvement with melanoma. |
| Lymphadenectomy | Lymphadenectomy or lymph node dissection is a surgical operation to remove one or more groups of lymph nodes. |
| Lymphoscintigraphy | An imaging technique used to identify the lymph drainage basin, determine the number of sentinel nodes, differentiate sentinel nodes from subsequent nodes, locate the sentinel node in an unexpected location, and mark the sentinel node over the skin for biopsy. It requires the injection of a radioisotope into the skin around the biopsy scar and a scan some hours later to determine to which lymph nodes the tracer has travelled. |
| Lymphovascular invasion | Tumour cells which have spread to involve the blood vessels and lymphatic vessels within the skin. |
| Magnetic resonance imaging (MRI) | A type of scan which uses a magnetic field and radio waves to produce images of sections of the body. |
| Mediastinal and hilar adenopathy | Enlargement of the pulmonary lymph nodes. |
| MEK inhibitors | Drugs that inhibit the mitogen‐activated protein kinase enzymes which are often upregulated in melanoma. |
| Meta‐analysis | A form of statistical analysis used to synthesise results from a collection of individual studies. |
| Metastases/metastatic disease | Spread of cancer away from the primary site to somewhere else through the bloodstream or the lymphatic system. |
| Micrometastases | Micrometastases are metastases so small that they can only be seen under a microscope. |
| Mitotic rate | Microscopic evaluation of number of cells actively dividing in a tumour. |
| Morbidity | Detrimental effects on health. |
| Mortality | Either (1) the condition of being subject to death; or (2) the death rate, which reflects the number of deaths per unit of population in relation to any specific region, age group, disease, treatment or other classification, usually expressed as deaths per 100, 1000, 10,000 or 100,000 people. |
| Multidisciplinary team | A team with members from different healthcare professions and specialties (e.g. urology, oncology, pathology, radiology, and nursing). Cancer care in the National Health Service (NHS) uses this system to ensure that all relevant health professionals are engaged to discuss the best possible care for that patient. |
| Nodal basin | Cluster of lymph nodes which filter lymphatic fluid as it travels around the body; clusters are located under the arm (axilla), in the groin, neck, chest and abdomen. |
| Oncology | The study of cancers. This term also refers to the medical specialty of cancer care, with particular reference to the use of radiotherapy or drugs to treat cancer. The medical specialty is often split into clinical oncology (doctors who use radiotherapy and drug treatment) and medical oncology (doctors who use drug treatment). |
| Palpation | Feeling with the fingers or hands as part of a clinical examination of the body. |
| Positron emission tomography (PET) | A nuclear medicine imaging technique whereby a radioactive glucose (usually 18FDG) is administered intravenously before a scan is conducted to create an image using colours to show where the FDG (or other radioactive tracer) has been taken up in the body. |
| Prevalence | The proportion of a population found to have a condition. |
| Prognostic factors/indicators | Specific characteristics of a cancer or the person who has it which might affect the patient’s prognosis. |
| Radiotherapy | The use of radiation, usually high energy x‐rays to control the growth of cancer cells. |
| RAS‐RAF‐MEK‐ERK signalling pathway | A chain of proteins which allow signals from a receptor on the surface of a cell to be sent to the DNA in the cell nucleus; a mutation in one of the proteins in the pathway is associated with the development of many cancers. |
| Recurrence | Recurrence is when new cancer cells are detected following treatment. This can occur either at the site of the original tumour or at other sites in the body. |
| Relapse | Where cancer starts to grow again after treatment. |
| Sagittal | Median plane dividing the body into left and right. |
| Sensitivity | In this context the term is used to mean the proportion of individuals with a disease who have that disease correctly identified by the study test. |
| Sentinel lymph node biopsy (SLNB) | A radioactive tracer and blue dye are injected into the skin surrounding the primary lesion and the 'sentinel' lymph nodes to which the tracer drains are located by imaging (usually lymphoscintigraphy) and then removed and examined for nodal metastatic spread that cannot be detected clinically or on imaging. |
| Signal transduction | Occurs when extracellular signalling molecules activate a specific receptor which then triggers cellular pathways. |
| Staging | Clinical description of the size and spread of a patient’s tumour, fitting into internationally agreed categories. |
| Stereotactic radiotherapy | A technique for delivering high dose radiotherapy very accurately to small areas inside the body which reduces the damage done by the radiotherapy to adjacent healthy tissues. |
| Subclinical (disease) | Disease that is usually asymptomatic and not easily observable, e.g. by clinical or physical examination. |
| Systemic treatment | Treatment, usually given by mouth or by injection, that reaches and affects cancer cells throughout the body rather than targeting one specific area. |
| Ultrasound | A type of scan in which high‐frequency sound waves are used to outline a part of the body. |
| Some of the definitions above have been obtained from the NICE Guideline for the management of melanoma (NICE 2015a). | |
| a. TNM staging categories for cutaneous melanoma | |||||||||
| Classification | |||||||||
| T | Thickness (mm) | Ulceration status/mitoses | |||||||
| Tis | NA | NA | |||||||
| T1 | <= 1.00 | a: Without ulceration and mitosis 1/mm2 | |||||||
| b: With ulceration or mitoses 1/mm2 | |||||||||
| T2 | 1.01 to 2.00 | a: Without ulceration | |||||||
| b: With ulceration | |||||||||
| T3 | 2.01 to 4.00 | a: Without ulceration | |||||||
| b: With ulceration | |||||||||
| T4 | > 4.00 | a: Without ulceration | |||||||
| b: With ulceration | |||||||||
| N | Number of metastatic nodes | Nodal metastatic burden | |||||||
| N0 | 0 | NA | |||||||
| N1 | 1 | a: Micrometastasis* | |||||||
| b: Macrometastasis† | |||||||||
| N2 | 2 to 3 | a: Micrometastasis* | |||||||
| b: Macrometastasis† | |||||||||
| c: In transit metastases/satellites without metastatic nodes | |||||||||
| N3 | 4 metastatic nodes, or matted nodes, or in transit metastases/satellites with metastatic nodes | ||||||||
| M | Site | Serum LDH | |||||||
| M0 | No distant metastases | NA | |||||||
| M1a | Distant skin, subcutaneous, or nodal metastases | Normal | |||||||
| M1b | Lung metastases | Normal | |||||||
| M1c | All other visceral metastases | Normal | |||||||
| Any distant metastasis | Elevated | ||||||||
| b. Anatomical stage groupings | |||||||||
| Clinical stage‡ | T | N | M | Pathological stage δ | T | N | M | ||
| 0 | Tis | N0 | M0 | 0 | Tis | N0 | M0 | ||
| IA | T1a | N0 | M0 | IA | T1a | N0 | M0 | ||
| IB | T1b | N0 | M0 | IB | T1b | N0 | M0 | ||
| T2a | N0 | M0 | T2a | N0 | M0 | ||||
| IIA | T2b | N0 | M0 | IIA | T2b | N0 | M0 | ||
| T3a | N0 | M0 | T3a | N0 | M0 | ||||
| IIB | T3b | N0 | M0 | IIB | T3b | N0 | M0 | ||
| T4a | N0 | M0 | T4a | N0 | M0 | ||||
| IIC | T4b | N0 | M0 | IIC | T4b | N0 | M0 | ||
| III | Any T | N > N0 | M0 | IIIA | T1‐ T4a | N1a | M0 | ||
| T1‐ T4a | N2a | M0 | |||||||
| IIIB | T1‐ T4b | N1a | M0 | ||||||
| T1‐ T4b | N2a | M0 | |||||||
| T1‐ T4a | N1b | M0 | |||||||
| T1‐ T4a | N2b | M0 | |||||||
| T1‐ T4a | N2c | M0 | |||||||
| IIIC | T1‐ T4b | N1b | M0 | ||||||
| T1‐ T4b | N2b | M0 | |||||||
| T1‐ T4b | N2c | M0 | |||||||
| Any T | N3 | M0 | |||||||
| IV | Any T | Any N | M1 | IV | Any T | Any N | M1 | ||
| LDH ‐ lactate dehydrogenase; M ‐ metastasis; N ‐ nodes; NA ‐ not applicable; T ‐ tumour; Tis ‐ melanoma in situ. *Micrometastases are diagnosed after sentinel lymph node biopsy. †Macrometastases are defined as clinically detectable nodal metastases confirmed pathologically. ‡Clinical staging is based on histology of the primary lesion and clinical (or radiological) examination. δPathological staging is assigned based on histology of the primary lesion and of the regional lymph nodes (either sentinel lymph node biopsy (SLNB) or complete lymph node dissection (CLND), where indicated. | |||||||||
