title: The bimanual ovarian palpation examination in the Prostate, Lung, Colorectal and Ovarian cancer screening trial: Performance and complications.
abstract: Objective To provide evidence about the performance characteristics and consequences of bimanual ovarian palpation. Setting and methods The Prostate, Lung, Colorectal and Ovarian cancer screening trial randomized 154,900 individuals to either an intervention or control arm. Enrolled eligible participants were aged 55-74, had no history of trial cancers, and no current treatment for cancer. Intervention arm women received CA-125 tests and transvaginal ultrasound. Bimanual ovarian palpation was offered annually during the first four years of the trial. Bimanual ovarian palpation-specific sensitivity and specificity were calculated, as were rates of diagnostic procedures and resulting complications following positive bimanual ovarian palpation screens. Results A total of 20,872 women received at least one bimanual ovarian palpation, with 50,498 total bimanual ovarian palpation examinations performed. The sensitivity and specificity of bimanual ovarian palpation were 5.1% (2/39) and 99.0% (49,957/50,459), respectively; no cases were detected by bimanual ovarian palpation alone. Rates for most follow-up procedures for abnormal results in women without ovarian cancer were higher among the group with another screening test positive, except for pelvic exam, where rates were similar. No complications were reported in the bimanual ovarian palpation-only positive group. Conclusion Low sensitivity of bimanual ovarian palpation alone and in combination with other tests argue against using bimanual ovarian palpation as a screening test for ovarian cancer in asymptomatic women.
authors.affiliation: Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.
authors.forename: Maryam
authors.initials: M
authors.lastname: Doroudi
authors.affiliation: Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.
authors.forename: Barnett S
authors.initials: BS
authors.lastname: Kramer
authors.affiliation: Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.
authors.forename: Paul F
authors.initials: PF
authors.lastname: Pinsky
mesh_terms: D000368:Aged; D014408:Biomarkers, Tumor / Q000032:analysis; D018394:CA-125 Antigen / Q000032:analysis; D055088:Early Detection of Cancer / Q000009:adverse effects / Q000379:methods*; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000009:adverse effects / Q000379:methods; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000175:diagnosis*; D010173:Palpation / Q000009:adverse effects / Q000379:methods*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014463:Ultrasonography
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen
keywords: Colorectal and Ovarian cancer screening trial; Lung; Prostate; bimanual ovarian palpation; complications; negative predictive value; ovarian cancer; positive predictive value; sensitivity; specificity