Blood Spot Self-administered Test and Assay
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19143
- University of Pennsylvania, Reproductive Research Unit
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
AMH pg/mL in dried bloodspot vs serum samples
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Clarisa Gracia, MD, MSCE, University of Pennsylvania
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 812735
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .