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Blood Spot Self-administered Test and Assay

2020年2月10日 更新者:University of Pennsylvania
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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19143
        • University of Pennsylvania, Reproductive Research Unit

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

The target population is 80 pre-menopausal women ages 18-45 years with normal menstrual cycles:

Aim 1: Total 80 subjects:

  • 30 cancer survivors
  • 30 similar aged healthy controls
  • 20 late reproductive aged women

Aim 2: Subset of 60 subjects:

  • 30 cancer survivors
  • 30 similar aged healthy controls

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Cancer Survivor
Pre-menopausal women who are cancer survivors ages 18-45 years with normal menstrual cycles.
Similar aged healthy controls
Pre-menopausal, healthy women ages 18-45 years with normal menstrual cycles
Late Reproductive Age
Pre-menopausal, healthy women of late reproductive age

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
AMH pg/mL in dried bloodspot vs serum samples
大体时间: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.
Day 1

次要结果测量

结果测量
措施说明
大体时间
Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic
大体时间:Day 1
A capillary blood sample from a finger-prick is applied to Whatman #903 filter paper, allowed to dry at room temperature for at least 4 hours, and then stored until analysis in the laboratory. Subjects willing to conduct a finger stick at home will collect an additional dried blood spot sample for secondary outcome measures. At home blood spot cards will be compared to those obtained in the office to determine adequacy of collection.
Day 1
Measures of user acceptability through subject report/feedback
大体时间:Day 1
Ease of use data reported by subject survey will be summarized to determine the overall acceptability of bloodspot collection and the potential for at- home use
Day 1
AMH pg/mL in cancer survivors vs. healthy control cohorts
大体时间:Day 1
AMH in dried blood spots vs. serum collected during the early follicular phase in 30 cancer survivors (15 exposed to low dose cancer therapy, 15 exposed to high dose cancer therapy) and 30 healthy similar aged controls will be compared using tests and multivariable linear regression
Day 1
FSH (mIU/mL) in dried bloodspot vs serum samples
大体时间:Day 1
Serum FSH ELISA assay results will be compared to FSH in a dried capillary blood sample applied to filter paper. Recovery of spiked ligands and sensitivity and specificity of the assays will be assessed.
Day 1
Inhibin B (pg/ml) in dried bloodspot vs serum samples
大体时间:Day 1
Serum Inhibin B ELISA assay results will be compared to capillary blood sample Inhibin B collected on filter paper and dried. Recovery of spiked ligands and sensitivity and specificity of the assays will be assessed.
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Clarisa Gracia, MD, MSCE、University of Pennsylvania

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年10月1日

初级完成 (实际的)

2016年6月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2015年3月17日

首先提交符合 QC 标准的

2019年2月11日

首次发布 (实际的)

2019年2月15日

研究记录更新

最后更新发布 (实际的)

2020年2月11日

上次提交的符合 QC 标准的更新

2020年2月10日

最后验证

2020年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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