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  • Case Study 1
  • Case Study 2
  • Case Study 3
  • PATIENT CASE STUDY 1

    Age: 52

    Menopausal Status: Premenopausal 

    Ethnicity: Caucasian

    Family History of Cancer: Unknown

    Personal History of Gynecologic Surgery: None

    Personal History of Cancer: None

     
    HISTORY

    Patient is a 52-year-old female who presents to her physician with complaints of pelvic pressure and pain. As part of her work-up the patient undergoes a trans-vaginal ultrasound. After abnormal findings the patient is then sent for a CT-scan of the abdomen and pelvis and a serum CA125 blood test.
     

    IMAGING AND CA125 RESULTS

    Ultrasound findings: A mass was identified on the left ovary that measured 10.7 X 15.9 X 8.5 cm.

    CT-scan findings: A large 10.7 x 15.9 x 8.5 cm complex pelvic mass. There are no findings of ascites, peritoneal nodules, omental caking, or lymphadenopathy.

    Tumor marker results: CA125 = 33.2 U/ml (normal <35 U/ml)

     

    HE4 & ROMA®

    HE4 = 470.8 pM (normal 150pM)

    ROMA Likelihood Value: 9.46 (ROMA score < 1.31 = Low likelihood of finding malignancy)

     

    Diagnosis

    This patient underwent surgery and was diagnosed with stage IIB endometroid ovarian cancer. Her surgery resulted in a total abdominal hysterectomy, bilateral salpingo-oophorectomy, and infracolic omentectomy, pelvic and periaortic lymph node dissection and appendectomy.

  • PATIENT CASE STUDY 2

    Age: 38

    Menopausal Status: Premenopausal

    Ethnicity: Asian/Pacific Islander

    Family History of Cancer: Paternal Aunt with Breast Cancer

    Personal History of Gynecologic Surgery: Left Salpingectomy

    Personal History of Cancer: None
     

    HISTORY

    A 38-year-old premenopausal Asian woman with a family history of breast cancer was found to have a mass on her right and left ovary following an ultrasound.
     

    IMAGING AND CA125 RESULTS

    Ultra Sound findings: Left ovary mass 6.0 X 6.3 X UNK cm. Right ovary mass Is 1.3 X 1.4 X UNK cm. An additional ultrasound performed five weeks prior revealed a complex cystic ovarian mass with anechoic cyst and hyperdense region.

    Tumor marker results: CA125 = 76.7 U/ml (normal <35 U/ml)
     

    HE4 & ROMA®

    HE4 = 59.42 pM (normal 150 pM)

    ROMA Likelihood Value: 1.18 (ROMA score < 1.31 = Low likelihood of finding malignancy)
     

    Diagnosis

    This patient underwent surgery and was diagnosed with a benign ovarian cyst, endometriosis and an endocervical polyp. Her surgery resulted in a left ovary cystectomy and biopsies of the cervical polyp and right ovary.

  • PATIENT CASE STUDY 3

    Age: 81

    Menopausal Status: Post-menopausal

    Ethnicity: Caucasian

    Family History of Cancer: None

    Personal History of Gynecologic Surgery: Left Salpingo-Oophorectomy, Total Abdominal Hysterectomy, Diagnosis unknown

    Personal History of Cancer: None
     

    CASE HISTORY

    The patient is an 81-year-old postmenopausal Caucasian woman with no family history of gynecologic or breast cancer, but with a personal history of gynecologic surgery.
      

    IMAGING AND CA125 RESULTS

    As part of her work-up the patient undergoes a CT Scan and tumor marker testing with the following results:

    CT-scan findings: A right 8.7 x 5.5 cm cystic solid mass extending from the vaginal cuff and indenting on the floor of the urinary bladder.

    Ultrasound findings: Right ovary mass, 7.4 X 6.3 X 5.8 cm.

    Tumor marker results: CA125 = 23.2 U/ml (normal <35 U/ml)
     

    HE4 & ROMA®

    HE4 = 417.1 pM (normal 150 pM)
    ROMA Likelihood Value: 6.19 (ROMA score < 2.77 = Low likelihood of finding malignancy)
     

    Diagnosis

    This patient underwent surgery and was diagnosed with Stage IIB endometroid ovarian cancer. Her surgery resulted in an exploratory laparotomy and radical resection of ovarian cancer including right salpingo-oophorectomy.

  • ROMA® INTENDED USE

    The Risk of Ovarian Malignancy Algorithm (ROMA) is a qualitative serum test that combines the results of HE4, CA125 II, and menopausal status into a numerical score.
      
    ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.

    PRECAUTION: ROMA should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.