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 measure

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.

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.

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.

What the quality statement means for each audience

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

NICE clinical guideline 122 recommendations 1.1.2.4 (key priority for implementation) and 1.1.1.4.

Data source

Structure: Local data collection.

Process: a) and b) Local data collection.

Definitions

Normal CA125 is defined as less than 35 IU/ml.

Raised CA125 is defined as 35 IU/ml or greater.

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

Symptoms suggesting ovarian cancer 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.

Non-ovarian cancer reasons for raised CA125 (from the United Kingdom Collaborative Trial for Ovarian Cancer Screening protocol list):

Physiological conditions:

  • ovulation

  • pregnancy

  • retrograde menstruation.

Benign gynaecological conditions:

  • endometriosis

  • benign ovarian cysts

  • uterine leiomyomata (fibroids).

Other non-malignant disease:

  • autoimmune disease (such as Sjogrens 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, lung)

  • disseminated malignancies from any site involving pleural or peritoneal surfaces

  • a proportion of:

    • non-Hodgkin's lymphoma

    • pancreatic cancers

    • cervical cancers

    • endometrial cancers.