Delayed Effects of Treatment in Cancer Survivors (DETECS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Serum anti-Mullerian hormone (AMH)
研究概览
简要总结
Hypotheses and Specific Aims: There is limited data on the long-term consequences of cancer therapy on young, reproductively aged cancer survivors. The investigators objective is to characterize some of these effects in the cancer population.
详细描述
Specific Aim 1: To compare markers of ovarian reserve between cancer survivors and healthy controls.
Hypothesis: Cancer survivors will have lower serum Anti-Mullerian Hormone (AMH) and antral follicle count (AFC), and higher Follicle Stimulating Hormone (FSH) than healthy controls.
Specific Aim 2: To compare cardio-metabolic, endocrine and bone profiles between cancer survivors and controls using a combination of anthropometric measures, fasting serum markers, and urinary markers of bone health.
Hypothesis: Cancer survivors will have higher total cholesterol and lower 25-OH vitamin D than healthy controls.
Specific Aim 3: To evaluate potential associations between ovarian reserve and markers of metabolism, obesity, and tumor bone health in young female cancer survivors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Exposed: Females between the ages of 18 and 45, at least 2 years from the completion of cancer therapy. Subjects will have one of the following cancer diagnoses: breast, leukemia, lymphoma, and/or any gynecologic cancer. Subjects must also be postmenarchal, have a uterus, at least one intact ovary, and must be willing and able to comply with study procedures. Subjects can be of any menopausal status and within 10 years post treatment.
- •Unexposed: Females between the ages of 18 and 45 with no prior history of cancer treatment.
排除标准
- •Exposed: Pregnancy, lactation within the previous 3 months, any medical condition other than cancer with a known correlation with premature menopause (i.e. Turner's syndrome, Fragile X, gonadal dysgenesis, polyglandular autoimmune syndrome, lupus, etc.), hormonal contraceptive use within 3 months.
- •Unexposed: Healthy controls with a history of polycystic ovary syndrome (PCOS), diabetes, thyroid dysfunction, hypertension, and hypercholesterolemia will be excluded in addition to cancer patients or survivors with one of the aforementioned diseases diagnosed prior to cancer diagnosis or treatment.
结局指标
主要结局
Serum anti-Mullerian hormone (AMH)
时间窗: Day 0 - 1 time measurement
Test of ovarian reserve via a blood sample.
次要结局
- High sensitivity C reactive protein (hsCRP)(Day 0 - 1 time measurement)
- 25-OH vitamin D(Day 0 - 1 time measurement)
- Antral Follicle Count(Day 0 - 1 time measurement)
- Body Mass Index (BMI)(Day 0 - 1 time measurement)
- Hemoglobin A1c(Day 0 - 1 time measurement)
- Follicle-stimulating hormone (FSH)(Day 0 - 1 time measurement)
- Estrone(Day 0 - 1 time measurement)
- Pregnanediol(Day 0 - 1 time measurement)
- Testosterone(Day 0 - 1 time measurement)
- Ovarian volume(Day 0 - 1 time measurement)
- Quality of Life(Day 0 - 1 time measurement)