Clinical trial: Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors (NCT00521118)

Eligibility criteria:
Inclusion Criteria:

          -  Patients who have had hydatidiform mole treated by evacuation and/or curettage and now
             meet the criteria of low risk GTN, as defined by the International Federation of
             Gynecology and Obstetrics (F.I.G.O.)/World Health Organization (W.H.O.) 2002 staging
             and risk scoring criteria:

               -  A plateau in the beta-hCG assay for 4 consecutive weekly levels over a period of
                  3 weeks or longer; that is, days 1, 7, 14, 21; for this study, a plateau will be
                  defined as less than a 10% decline using as a reference the initial value in the
                  series of values taken over a period of 3 weeks; OR

               -  A rise in the beta-hCG assay of 3 consecutive measurements, or longer, over at
                  least a period of 2 weeks or more; days, 1, 7, 14; for this study, a rise will be
                  defined as an increase of greater than 20% taking as a reference the initial
                  value in the series of values taken over the 2-week period; OR

               -  When the beta-hCG level remains elevated above normal for 6 months or longer

          -  Patients must have a clinically significant elevated beta-hCG level of greater than 20
             mIU/ml

          -  Patients must have non-metastatic low risk GTN with a W.H.O. 2002 risk score of no
             greater than 6

          -  Patients must have no metastatic disease as determined by the pelvic examination,
             pelvic ultrasound, and chest x-ray

          -  Patients must have signed an approved informed consent and Health Insurance
             Portability and Accountability Act (HIPAA) authorization

          -  Patients must have a Gynecologic Oncology Group (GOG) performance status of 0 or 1

          -  Patients must have histologically confirmed complete or partial mole

          -  Patients must agree to use an accepted method of contraception (oral contraceptives,
             birth control patches, Depo-Provera, diaphragm, contraceptive foam and condom, or
             male/female sterilization)

          -  Patients must meet pre-entry requirements

        Exclusion Criteria:

          -  Patients who do not have persistent low-risk GTN

          -  Patients with any evidence of metastatic disease beyond the uterus

          -  Patients with persistent or recurrent GTN (same gestation) that have already been
             treated with chemotherapy

          -  Patients with other invasive malignancies, with the exception of non-melanoma skin
             cancer, patients who have had any evidence of the other cancer present within the last
             5 years or patients whose previous cancer treatment contraindicates this protocol
             therapy

          -  Patients with histologically confirmed choriocarcinoma, placental site trophoblastic
             tumor (PSTT) or epithelioid trophoblastic tumor (ETT) on the first curettage

          -  Patients who refuse to use an accepted method of contraception

          -  Patients who have had more than one curettage for the management of the current
             disease or who have undergone hysterectomy
Female
No healthy subjects accepted to join the trial.



Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction