Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00521118
Study Brief:
Protocol Section:
NCT00521118