Evidence
Surveillance decision
We will plan an update of these sections of the guideline:
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Establishing a diagnosis in secondary care
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For women with suspected ovarian cancer, what serum tumour marker tests should be routinely carried out to aid in diagnosis?
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Detection in primary care
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For women with suspected ovarian cancer, what are the most effective first tests in primary care?
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What are the risk factors for ovarian cancer that should be identified in primary care?
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Reason for the decision
We found 91 new studies relevant to the guideline through the surveillance process. This included evidence identified for detection in primary care, management of stage I and II–IV ovarian cancer, establishing a diagnosis in secondary care and support needs of women with newly diagnosed ovarian cancer. Topic expert feedback noted that there may be new studies on human epididymis protein 4 (HE4) and cancer antigen 125 (CA125) for the diagnosis of ovarian cancer, although no specific studies were highlighted.
New evidence and stakeholder consultation feedback that could affect recommendations was identified. Topic experts, including those who helped to develop the guideline, advised us about whether the following sections of the guideline should be updated:
Establishing the diagnosis in secondary care
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For women with suspected ovarian cancer, what serum tumour marker tests should be routinely carried out to aid in diagnosis?
CG122 did not include substantial evidence on HE4 and recommended CA125 as the serum tumour marker for the diagnosis of ovarian cancer. New evidence at the 4‑year surveillance of CG122 provides further comparative data on the diagnostic accuracy of HE4. The newly identified systematic reviews and diagnostic studies indicate that HE4 has a higher specificity than CA125 but similar sensitivities for the diagnosis of ovarian cancer. Topic experts noted that an increased specificity may be useful in the pre‑menopausal population as it may prevent unnecessary referrals.
The topic experts advised that HE4 is not widely used or available in the NHS or a primary care setting. However stakeholders highlighted at consultation that there may be role for HE4 in the clinical pathway for the diagnosis of ovarian cancer. The consultation identified a number of diagnostic accuracy studies relating to the serum tumour marker tests, indicating that HE4 has a higher specificity than CA125, which is the tumour marker recommended by CG122 for the diagnosis of ovarian cancer.
New evidence was found on the Risk for Ovarian Malignancy Algorithm (ROMA). The topic experts noted that ROMA takes into account menopausal status and in pre‑menopausal women the ROMA score may reduce the number of patients going to tertiary care.
Comments received from stakeholders at consultation expressed a need for NICE to review the recommendations on serum tumour markers for the diagnosis of ovarian cancer, in particular the role of HE4 and ROMA.
Decision: This review question should be updated.
Detection in primary care
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For women with suspected ovarian cancer, what are the most effective first tests in primary care?
New evidence comes from two prospective cohort studies and one prognostic study. Two new prospective cohort studies were non‑comparative to CA125 or ultrasound alone and only investigates use in combination. The guideline recommends CA125 as the tumour marker to be used in primary care. Although the new evidence does not indicate a need for update, the question may be impacted as the question above, on serum tumour markers, is to be updated.
Decision: This review question should be updated.
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What are the risk factors for ovarian cancer that should be identified in primary care?
Feedback from stakeholder consultation indicated that there is a gap in the recommendations in CG122 on risk factors for ovarian cancer in primary care. This is also not covered by any NICE guidance. This new question will be added to the guideline. This would align with the recently published referral for suspected cancer NICE guideline.
Decision: This new review question should be added to the guideline.
See how we made the decision for further information.
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