Ovarian Aging in Women Newly Diagnosed With Low Grade Glioma Treated With Temozolomide (Temodar®)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Ovarian Aging (AFC and Hormones)
研究概览
简要总结
The purpose of this study is to look at how a chemotherapy treatment (Temozolomide, also called Temodar) affects the process of ovarian aging which is measured by a decline in ovarian follicle count, in patients with Low Grade Glioma (LGG). It is important to know if different patient factors and Temozolomide influence the rate of ovarian aging in women with LGG who have good long-term survival rates. This will allow better counseling about the effects of this particular chemotherapy agent on fertility in women.
详细描述
Understanding how Temozolomide influences ovarian aging would be important information for physicians to predict the possibility of infertility (the inability to become pregnant) following recovery from Temozolomide treatment. Physicians would like to provide better individualized recommendations for cancer patients regarding timing of planned treatment and future pregnancy.
We will do this by comparing data from the women being treated for Low Grade Glioma with Temozolomide to a similar group of women who have been unaffected by cancer or cancer treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women ages 18-44 newly diagnosed with LGG
- •Patients fulfill the inclusion criteria for UCSF Protocol Number: CC #99102 " A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients with Supratentorial Low Grade Glioma"
- •Patients with histologically proven supratentorial low grade glioma.
- •Patients may or may not have had a surgical resection.
- •Patients must be expected to live the length of study
- •Patients must be able to provide informed consent according to institutional guidelines.
排除标准
- •Prior ovarian resection, unilateral or bilateral oophorectomy, hysterectomy or radiation to pelvic region.
- •Pregnancy or breast feeding.
- •Diagnosis of another malignancy, unless the patient was diagnosed at least 2 years earlier and has been disease-free for at least 6 months following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
- •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- •Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse
- •Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient.
结局指标
主要结局
Ovarian Aging (AFC and Hormones)
时间窗: Every 3 months for 1 year
Transvaginal Ultrasound will be use to measure Antral Follicle Counts (AFC) and blood will be drawn to measure hormones (FSH, LH, estradiol, estrone, AMH, SHBG, testosterone, and inhibin B).
次要结局
未报告次要终点