BACKGROUND. Ovarian cancer is the most lethal gynaecological cancer, particularly due to the
non-specificity of symptoms and the lack of a screening strategy. The general population has a
1-1.5% lifetime risk of developing ovarian cancer. Women with a pathogenic mutation in the
BRCA1 or BRCA2 genes have a higher lifetime risk of developing ovarian cancer, being at the age
of 70, 39-44% for BRCA1 and 11-18% for BRCA2. Currently, the recommendation with the most
evidence in terms of risk reduction is risk-reducing prophylactic bilateral salpingo-
oophorectomy. Nevertheless, some women refuse or postpone this surgery due to the
subsequent effects. Thus, they are offered a six-monthly screening strategy based on
transvaginal ultrasound (TVUS) and CA125 marker analysis. This strategy presents a false-
positive rate of 15%, with the consequence of performing unnecessary surgeries, since when
these tests are altered the woman is considered candidate for individualized surgery.
OBJECTIVES. The main objective of this study is to determine whether the application of the
combined follow-up strategy based on transvaginal ultrasound, serum tumour marker CA125
and PapSEEK is more specific than the current follow-up strategy based on transvaginal
ultrasound and serum tumour marker CA125 , in the context of the six-monthly follow-up for
the early detection of ovarian cancer in women who carry a pathogenic mutation in the BRCA1
or BRCA2 genes and who are candidates for surgery after presenting a transvaginal ultrasound
and/or an altered CA125. Secondary objectives aim to determine the sensibility of the study
strategy and assess patient acceptability.
DESIGN AND METHODOLOGY. This study was designed as a cross-sectional study. It will be a
multicentre study performed in 9 Catalan hospitals.
PARTICIPANTS. 62 women with a pathogenic mutation in the BRCA1/2 genes who undergo the
current six-monthly follow-up strategy and have these tests altered (CA125 > 35 U/mL and/or
TVUS O-RADS ≥ 2)
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