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临床试验/NCT03840824
NCT03840824已完成不适用

Blood Spot Self-administered Test and Assay

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
AMH pg/mL in dried bloodspot vs serum samples

研究概览

简要总结

The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45 years with normal menstrual cycles.

详细描述

Recent advances in cancer diagnosis and treatment have led to greater survival rates in patients with malignancies. However, these life-saving treatments, especially alkylating agents, often lead to premature ovarian failure, infertility and related long-term health problems. It is difficult to predict whether, and the extent to which, patients will experience these problems. There are no early clinical signs of decreased fertility potential; even young women who maintain cyclic menses after therapy are at high risk of infertility, early menopause and related health problems. Preliminary studies suggest that several surrogate measures of fertility potential are different in cancer survivors compared with controls. These include follicle stimulating hormone (FSH), estradiol, anti-mullerian hormone (AMH) and inhibin B. Large longitudinal studies are needed to validate these measures with gold standard outcomes such as pregnancy rates, pregnancy outcomes and time to menopause. The main impediment to assessing the value of these markers and generating data that is useful to cancer survivors is the need for frequent and timed blood samples.

Daily or frequent trips to the clinical center are not practical and reduce the compliance of even the most motivated patients. The hypothesis that will be tested by this study is that blood spot assays can be developed that provide robust, personalized data for surrogate markers of reproductive function which can be used to assess reproductive potential in women; furthermore, bloodspots collected at home are an acceptable method for reproductive hormone measurement in women with and without a history of cancer. The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of subjects.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult females
  • Age between 18-45 years
  • Premenopausal (defined as menses in the past 12 months)
  • Postmenarchal
  • Presence of an intact uterus and two ovaries
  • Ability and willingness to comply with study protocol

排除标准

  • Pregnancy within the previous 3 months
  • Lactation within the previous 3 months

结局指标

主要结局

AMH pg/mL in dried bloodspot vs serum samples

时间窗: Day 1

Serum AMH ELISA assay results will be compared to capillary blood sample AMH collected on filter paper and dried. Recovery of spiked ligands, sensitivity and specificity of the assays will be also assessed.

次要结局

  • Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic(Day 1)
  • Measures of user acceptability through subject report/feedback(Day 1)
  • AMH pg/mL in cancer survivors vs. healthy control cohorts(Day 1)
  • FSH (mIU/mL) in dried bloodspot vs serum samples(Day 1)
  • Inhibin B (pg/ml) in dried bloodspot vs serum samples(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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