Blood Spot Self-administered Test and Assay
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19143
- University of Pennsylvania, Reproductive Research Unit
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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AMH pg/mL in dried bloodspot vs serum samples
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Clarisa Gracia, MD, MSCE, University of Pennsylvania
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 812735
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