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Background
Next Steps
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Cervical Cancer - Disease Context
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HPV and Cervical Cancer
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Life Course Approach to Cervical Cancer Prevention and Control
Girls 9-14 years Women > 30 years of age All women as needed
• HPV vaccination Treatment of invasive cancer at any age and
Girls and boys, as appropriate “Screen and treat” – single visit approach palliative care
•Health information and warnings about •Ablative surgery
tobacco use • Point-of-care rapid HPV testing for high risk •Radiotherapy
•Sexuality education tailored to age & culture HPV types •Chemotherapy
•Condom promotion/provision for those • Followed by immediate treatment •Palliative Care
engaged in sexual activity • On site treatment
•Male circumcision
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Cervical Cancer: an Avoidable NCD with Gross Inequities
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May 2018: WHO Director General’s Call to Action to Eliminate
Cervical Cancer as a Public Health Problem
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Increasing Access to Interventions for control towards
elimination
Control: Targets of
90% and
Elimination by
70% 2085 /2090
Cervical cancer cases/100,000
Elimination at 4 / 100,000
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2020-2030 Acceleration plan towards elimination
The 2030 targets and elimination threshold are subject to revision depending on the outcomes of the
modeling and the WHO approval process
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Strategy towards the elimination of cervical cancer as a
global public health problem: key outputs by 2030
1
Guiding principles: life course and public health approach, social justice and
equity, integrated people-centered health services
KEY OUTPUTS
2 Increased
Increased
coverage of
Increased coverage of
diagnosis &
coverage of HPV screening &
treatment for
vaccination treatment of pre-
invasive cancer
cancer lesions
and palliative care
3 Accelerators
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5.1 Vaccinate: key component of the comprehensive
prevention and control strategy
Two safe, effective vaccines that prevent infections from high-risk HPV
types 16 and 18 are presently licensed in most countries.
Vaccines do not cover all cancer-causing HPV types and do not treat pre-
existing infections; thus, ongoing screening is mandatory.
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5.2 Screen & Treat: reduces loss to follow-up, and can reduce
the time lag for women to receive treatment
Target: 70% of women screened with an HPV test at 35 and 45 years of age
& 90% of the one screened positive managed appropriately
Devices that can detect HPV, cytology and VIA play an important role in
cervical cancer prevention programs.
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5.3 Invasive Cancer Management
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Working Groups: Taking Forward the Roadmap
of Activities and Stakeholder Coordination
Technical Task Team
(Membership: WHO Co-Chair; invitations to agencies and partners to join the 7 Working Groups)
WG 1 WG 2 WG 4 WG 5 WG 6 WG 7
Cervical Advocacy com- Impact Increasing Monitoring Research
WG 3 Cancer munications, & Modeling, Access to and
Elimination civil society Costing and Inter- Surveillance
WHO Recom- Strategic mobilization Financing ventions
mendations Documents and
(internal only) and Action engagement
Plan
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Agenda
Background
Next Steps
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Screen & Treat
Technical guidance and specifications - why?
A key gap identified was the lack of technical guidance and specifications
for the majority of cervical cancer related tests and treatment
technologies.
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Screen & Treat
Technical guidance and specifications – what?
Current efforts will cover technical guidance and specifications for the
diagnostics and treatment of precancerous lesions for the prevention of
cervical cancer in terms of:
– Quality
– Performance
– Operational characteristics
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Screen & Treat
Technical guidance and specifications – how?
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Agenda
Background
Next Steps
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Outline for the forthcoming Technical Guidance and
specification document
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HPV NAT IVD (1 of 4): Background
HPV is a relatively small double stranded DNA virus that is present and
accessible in infected exfoliated cell specimens, allowing detection by
molecular nucleic acid tests (NAT) that utilize primers and probes to
amplify DNA or RNA targets
HPV NATs for qualitative detection of high risk genotypes cover a range
of specifications:
– DNA and RNA-based technologies
• rtPCR, probe hybridization, invader signal, microarray PCR, TMA, NASBA
– Reporting out pooled and/or individual genotypes
– Internal controls for sample adequacy and to rule out inhibitory substances
– Manual, high throughput automated and point-of-care methodology
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HPV NATs (2 of 4): Considerations When Implementing
Specimen acquisition:
– Health-care provider collected
• Need for exam table/light, specula, gloves, sterilization equipment
– Self-collected
• In clinic or home-based
Performance of NATs:
– Laboratory or point-of-care
– Infrastructure and equipment considerations
• Are electricity, running water, refrigeration/freezing required?
• Possible need for specimen racks, pipettes/tips, centrifuge, heating blocks, disinfectants
– Workflow: batch or single samples, throughput requirements
Interpretation of Results
– Health-care provider training in interpretation and next steps essential
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HPV NATs (3 of 4): Strengths and Limitations
Workflow flexibility:
– Laboratory- vs clinic-based
– Manual, automated or point-of-care platforms
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HPV NAT IVD (4 of 4): Technical Specification Guidance
Clinical Performance:
– At least 90% of sensitivity of the designated comparator for detection of CIN2 or
greater
– Not less than 98% of specificity of the designated comparator
– lower bound of agreement not less than 87% for inter- and intra-laboratory
reproducibility
Analytic performance:
– Sensitivity: (Limit of Detection) dependent on genotype detected, characteristics of
particular test
– Specificity: cross-reactivity with a panel of organisms (to include those common to
female urogenital tract) and low risk HPV genotypes; assessment of effect of
endogenous and exogenous interfering substances in cervical specimens
Operational requirements
– Infrastructure, equipment, specimen throughput, reagent storage, waste disposal:
key considerations that are dependent on particular test and need to be addressed
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VIA (1 of 2): Background
Visual Inspection with Acetic Acid (VIA) is a technique for the detection
of pre-cancerous or cancerous lesions in the cervix.
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VIA (2 of 2): Technical Specification Guidance
Glacial (water-free) acetic acid is the base for this medium; household
white vinegar is another source of concentrated acetic acid.
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Colposcope (1 of 3): Background
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Colposcope (2 of 3): Strengths and limitations
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Colposcope (3 of 3): Technical Specification Guidance
Manual or autofocus.
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Thermal Ablation (1 of 3): Background
Thermal ablation has been used effectively in some settings for many
years, especially for the treatment of endometriosis.
Only recently have handheld devices come on the market, making the
method more suitable for LRS (benchtop models are cumbersome and
reliant on mains, though highly effective).
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Thermal Ablation (2 of 3): Strengths and limitations
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Thermal Ablation (3 of 3): Technical Specification Guidance
Compatible for use with at least two probes with different-sized tips
– Standard tip diameters: 16 mm and 19 mm
– A flat tip and a tip with a nipple for placement into the cervical canal
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Cryotherapy (1 of 3): Background
It takes ~15 minutes and is generally well tolerated, associated with only
mild discomfort, and thus does not require anaesthesia. The treated area
takes about a month to regenerate.
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Cryotherapy (2 of 3): Strengths and limitations
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Cryotherapy (3 of 3): Technical Specifications Overview
The probe has a closed system in which the cryogen travels to and
circulates in the probe head, then back through probe for exhausting.
(An open system is not suitable for CO2 and N2O)
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LEEP (1 of 3): Background
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LEEP (2 of 3): Strengths and limitations
The histology specimen can have charred borders, making lesion margins
difficult to interpret.
LEEP:
– Relies on dependable, quality power supply
– Uses sophisticated equipment that requires maintenance.
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LEEP (3 of 3): Technical Specifications Overview
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Agenda
Background
Next Steps
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Current timeline
•Develop
Document
comprehensive Draft Review Print
finalization
draft
Consultants will There are two review Authors will address The final document
author individual cycles: questions, will be sent to print.
chapters and WHO 1)During the Global comments and/or
will compile chapters Forum for Medical concerns raised
into a single Devices; and, during the review.
comprehensive draft. 2)Review by GMTA/ After which WHO will
HTAi & expert work on layout,
group design, technical
editing and proofing.
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Output: A new technical guidance and specification document!
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Next steps
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