Clinical trial NCT03840824: Blood Spot Self-administered Test and Assay
Official title: Blood Spot Self-administered Test and Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysfunction; Endocrine
Effects of Chemotherapy
Premature Ovarian Failure
Keywords: healthy
premenopausal
postmenarchal
chemotherapy
alkylating agent
alkylator
high dose cancer therapy
low dose cancer therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: AMH pg/mL in dried bloodspot vs serum samples
timeFrame: Day 1
Secondary outcomes:
measure: Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic
timeFrame: Day 1
measure: Measures of user acceptability through subject report/feedback
timeFrame: Day 1
measure: AMH pg/mL in cancer survivors vs. healthy control cohorts
timeFrame: Day 1
measure: FSH (mIU/mL) in dried bloodspot vs serum samples
timeFrame: Day 1
measure: Inhibin B (pg/ml) in dried bloodspot vs serum samples
timeFrame: Day 1
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Clarisa Gracia, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDade TW, Woodruff TK, Huang YY, Funk WE, Prewitt M, Kondapalli L, Gracia CR. Quantification of anti-Mullerian hormone (AMH) in dried blood spots: validation of a minimally invasive method for assessing ovarian reserve. Hum Reprod. 2012 Aug;27(8):2503-8. doi: 10.1093/humrep/des194. Epub 2012 Jun 6.