Clinical trial NCT01879436: The Effect of Human Placental Explants and Pregnant Women Sera on Cancer Cells
Official title: The Effect of Human Placental Explants and Pregnant Women Sera on Cancer Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Pregnancy, Placenta, Cancer
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women Age 18-45. Pregnant (6-9 weeks) and non pregnant women.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Placentae that were destroyed during pregnancy termination.

Primary outcomes:
measure: Cancer cell phenotype (in the laboratory)
timeFrame: Baseline, 24 hours and 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Oncogenetic Laboratory, Meir Medical Center
Study officials:
affiliation: Meor Medical Center, Kfar-Saba, Israel
name: Michael Lishner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.