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临床试验/NCT01879436
NCT01879436已完成不适用

The Effect of Human Placental Explants and Pregnant Women Sera on Cancer Cells

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Cancer cell phenotype (in the laboratory)

研究概览

简要总结

Maternal malignancy during pregnancy is estimated to occur in 1 out of 1000 pregnancies. Controversy exists regarding the effect of pregnancy on cancer prognosis. Gestational hormones and pregnancy-related growth factors may induce a more aggressive behavior in malignant cells. However, metastasis to the products of conception is rare. In the current study investigators wish to analyze the effect of placental explants on cancer cells (cervical, ovarian, thyroid, melanoma, lymphoma, leukemia and breast)phenotype (cell death, proliferation, migration , invasion), signaling pathway, mRNA, miRNA and protein expression.

详细描述

In the Oncogenetic laboratory cancer cells will be exposed to first trimester human placental explants or to serum collected from pregnant women. As a control cancer cells will be cultured alone or in the presence of sera collected from young (18-45) non pregnant women.

Placentae, 6-9 weeks gestational age, will be retrieved from terminated normal pregnancies. The placenta will be taken after pregnancy termination, thus, no harm will be caused for the women.

The sera will be collected from the women by an authorized physician. It will be taken from: 1. the vein of the non pregnant women and volunteered pregnant women. 2. from the same branula that will be introduced into the pregnant women as a routine during pregnancy termination procedure.

Following culture investigators will analyze the cancer cells phenotype (cell death, proliferation, migration, and invasion), signaling pathway, mRNA, miRNA and protein expression.

Sera will be collected from 50 pregnant women and 50 non pregnant women. Placentae will be collected from 50 pregnant women.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy women
  • Pregnant (6-9 weeks) and non pregnant women.

排除标准

  • Placentae that were destroyed during pregnancy termination.

结局指标

主要结局

Cancer cell phenotype (in the laboratory)

时间窗: Baseline, 24 hours and 72 hours

The measure of outcome is composite and includes several changes: Changes in: * cell death (% from tested cells) * cell cycle (% cells in G1, G2 and S phases) * cell migration (% closure in Scratch test) * cell invasion (% cells passing through membrane in Transwell assay) * RNA repertoire (Fold change) * miRNA repertoire (Fold change)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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