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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879436
• Other study ID #: 0053-13-MMC
• Status: Completed
• Start date: November 2013
• Est. completion date: July 2019

Study information

• Verified date: October 2020
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy women

• Age 18-45.

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

Exclusion Criteria:

• Placentae that were destroyed during pregnancy termination.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Israel	Oncogenetic Laboratory, Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Tartakover-Matalon S, Mizrahi A, Epstein G, Shneifi A, Drucker L, Pomeranz M, Fishman A, Radnay J, Lishner M. Breast cancer characteristics are modified by first trimester human placenta: in vitro co-culture study. Hum Reprod. 2010 Oct;25(10):2441-54. doi: 10.1093/humrep/deq227. Epub 2010 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer cell phenotype (in the laboratory)	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)	Baseline, 24 hours and 72 hours