Development of an ovarian cancer symptom index
- Study type
- Other
- Design
- Case-control study based on a symptom questionnaire, with participants randomly divided into an exploratory group and a confirmatory group
- Sample size
- 149 women with ovarian cancer, 255 women in a screening programme and 233 women referred for pelvic/abdominal ultrasound
- Source
- Cancer · 2007
In plain words
Early ovarian cancer often causes vague symptoms, but this study showed that some symptoms can be a warning sign if they are new (less than a year old) and happen often (more than 12 days a month). These symptoms are pain in the pelvis or abdomen, needing to pass urine often or urgently, bloating or a swollen abdomen, and difficulty eating or feeling full quickly. Having these symptoms does not necessarily mean cancer, but if they continue you should see a doctor.
Key results
Treatment arms and regimens
149 women with ovarian cancer who completed the symptom questionnaire. There was no drug intervention; dosing details do not apply.
255 women taking part in a screening programme who completed the symptom questionnaire.
233 women referred for pelvic/abdominal ultrasound who completed the symptom questionnaire.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
149 women with ovarian cancer (cases) and two control groups: 255 women taking part in a screening programme and 233 women referred for pelvic/abdominal ultrasound. All women were invited to complete a symptom questionnaire. Exact inclusion criteria are not given in the abstract and are in the full text of the paper.
Endpoints
The type, frequency, severity and duration of symptoms were compared between cases and controls. Logistic regression in the exploratory group identified independent predictors of cancer, which were then used to build a symptom index. The sensitivity and specificity of the index were tested in the confirmatory group.
Safety and side effects
This was not an interventional study, and no safety/adverse event data are reported in the abstract.
Clinical significance and place in guidelines
This study showed that a simple symptom-based index can help identify women at risk of ovarian cancer and may be a basis for earlier diagnosis. Based on the abstract, screening of the general population is not recommended and the index is not a definitive diagnostic tool; its sensitivity for early-stage disease was limited. The place of this index in clinical guidelines should be checked separately.
Limitations
The sensitivity of the index for early-stage disease was relatively low (56.7). The design is case-control, and the control groups were women in a screening programme or referred for ultrasound, not the general population. Other limitations should be checked in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.