title: Ovarian cancer screening: development of the risk of ovarian cancer algorithm (ROCA) and ROCA screening trials.
abstract: Ovarian cancer is most often detected in late stage when prognosis is poor; in contrast, prognosis is excellent when detection occurs in early stage. Early detection with regular biomarker tests may reduce disease-specific mortality. Two screening trials with annual CA125 greater than 35 U/mL demonstrated promise. Before undertaking larger trials, statistical analyses of serial CA125 levels showed each woman has her own baseline level; and in ovarian cancer cases, CA125 rose rapidly from her baseline after a change point. Improved early detection of ovarian cancer may result if each woman were tested for the presence of a change-point CA125 profile. Using the serial CA125 from the completed trials, a statistical method was developed to measure the probability a change-point had occurred. Subsequent screening trials implemented the risk of ovarian cancer algorithm (ROCA) in which screening decisions are made based on the risk of having a change point. Development of ROCA is described, and ROCA trials are listed.
authors.affiliation: Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA. sskates@gmail.com
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Skates
mesh_terms: D000328:Adult; D000465:Algorithms; D018394:CA-125 Antigen / Q000097:blood*; D002986:Clinical Trials as Topic; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008565:Membrane Proteins / Q000097:blood*; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000097:blood*; D018570:Risk Assessment; D012680:Sensitivity and Specificity
chemical_list: D018394:CA-125 Antigen; C451759:MUC16 protein, human; D008565:Membrane Proteins