Blood Spot Self-administered Test and Assay

Completed

• Conditions: Effects of Chemotherapy; Dysfunction; Endocrine; Premature Ovarian Failure

• Registration Number: NCT03840824
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2015-03-17
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AMH pg/mL in dried bloodspot vs serum samples	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania, Reproductive Research Unit; 🇺🇸 Philadelphia, Pennsylvania, United States