Quality standard

Quality statement 3: Advice

Quality statement

Women with normal CA125, or raised CA125 but normal ultrasound, with no confirmed diagnosis but continuing symptoms, are reassessed by their GP within 1 month.

Quality measures

The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.

Structure

Evidence of local arrangements and written clinical protocols to ensure women with normal CA125, or raised CA125 but normal ultrasound, with no confirmed diagnosis but continuing symptoms, are reassessed by their GP within 1 month.

Data source: Local data collection.

Process

a) Proportion of women with normal CA125 and no confirmed diagnosis but continuing symptoms, who are reassessed by their GP within 1 month.

Numerator – the number of women in the denominator who are reassessed by their GP within 1 month.

Denominator – the number of women with normal CA125 and no confirmed diagnosis but continuing symptoms.

Data source: Local data collection.

b) Proportion of women with raised CA125 but normal ultrasound and no confirmed diagnosis but continuing symptoms, who are reassessed by their GP within 1 month.

Numerator – the number of women in the denominator who are reassessed by their GP within 1 month.

Denominator – the number of women with raised CA125 but normal ultrasound, and no confirmed diagnosis but continuing symptoms.

Data source: Local data collection.

What the quality statement means for different audiences

Service providers ensure systems and written clinical protocols are in place for women with normal CA125, or raised CA125 but normal ultrasound, with no confirmed diagnosis but continuing symptoms, to be reassessed by their GP within 1 month.

GPs proactively reassess women who have normal CA125, or raised CA125 but normal ultrasound, with no confirmed diagnosis but continuing symptoms, within 1 month.

Commissioners ensure they commission services that reassess women who have normal CA125, or raised CA125 but normal ultrasound, with no confirmed diagnosis but continuing symptoms, by their GP within 1 month.

Women with normal CA125 results, or raised CA125 but a normal ultrasound scan, with no confirmed diagnosis but continuing symptoms, are reassessed by their GP within 1 month.

Source guidance

Ovarian cancer: recognition and initial management. NICE guideline CG122 (2011), recommendations 1.1.2.4 (key priority for implementation) and 1.1.1.4

Definitions of terms used in this quality statement

Normal CA125

CA125 of less than 35 IU/ml.

Raised CA125

CA125 of 35 IU/ml or greater.

Within 1 month

One month starts from receipt of the normal CA125 or normal ultrasound result.

Symptoms suggesting ovarian cancer

Symptoms include:

  • persistent abdominal distension (women often refer to this as 'bloating')

  • feeling full and/or loss of appetite

  • pelvic or abdominal pain

  • increased urinary urgency and/or frequency

  • unexplained weight loss

  • fatigue

  • changes in bowel habit or

  • symptoms that suggest irritable bowel syndrome if the woman is 50 or over.

[Adapted from NICE's guideline on ovarian cancer, recommendations 1.1.1.2, 1.1.1.3 and 1.1.1.5]

Non-ovarian cancer reasons for raised CA125

Physiological conditions:

  • ovulation

  • pregnancy

  • retrograde menstruation.

Benign gynaecological conditions:

  • endometriosis

  • benign ovarian cysts

  • uterine leiomyomata (fibroids).

Other non-malignant disease:

  • autoimmune disease (such as Sjogren's syndrome, polyarteritis nodosa, systemic lupus erythematosus)

  • sarcoidosis

  • benign gastrointestinal diseases (such as colitis, diverticulitis)

  • chronic active hepatitis

  • cirrhosis

  • pericarditis

  • pancreatitis (acute and chronic)

  • renal disease with serum creatinine greater than 2.0.

Non-ovarian malignant conditions:

  • malignant ascites

  • disseminated malignancy (such as breast and lung)

  • disseminated malignancies from any site involving pleural or peritoneal surfaces

  • a proportion of:

    • non-Hodgkin's lymphoma

    • pancreatic cancers

    • cervical cancers

    • endometrial cancers.

[Adapted from the United Kingdom Collaborative Trial for Ovarian Cancer Screening protocol list]