Blood Spot Self-administered Test and Assay
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19143
- University of Pennsylvania, Reproductive Research Unit
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Cancer Survivor
Pre-menopausal women who are cancer survivors ages 18-45 years with normal menstrual cycles.
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Similar aged healthy controls
Pre-menopausal, healthy women ages 18-45 years with normal menstrual cycles
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Late Reproductive Age
Pre-menopausal, healthy women of late reproductive age
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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AMH pg/mL in dried bloodspot vs serum samples
時間枠：Day 1
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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.
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Day 1
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic
時間枠：Day 1
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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.
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Day 1
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Measures of user acceptability through subject report/feedback
時間枠：Day 1
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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
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Day 1
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AMH pg/mL in cancer survivors vs. healthy control cohorts
時間枠：Day 1
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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
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Day 1
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FSH (mIU/mL) in dried bloodspot vs serum samples
時間枠：Day 1
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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.
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Day 1
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Inhibin B (pg/ml) in dried bloodspot vs serum samples
時間枠：Day 1
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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.
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Day 1
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協力者と研究者
捜査官
- 主任研究者：Clarisa Gracia, MD, MSCE、University of Pennsylvania
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 812735
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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