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Completed

NCT Number: NCT01879436

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Oncogenetic Laboratory, Meir Medical Center

Kfar Saba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women
  • Age 18-45.
  • Pregnant (6-9 weeks) and non pregnant women.

Exclusion criteria

  • Placentae that were destroyed during pregnancy termination.

Treatment and study plan

Primary outcomes

  1. Cancer cell phenotype (in the laboratory)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2013
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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