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

Clalit Health Services

Status: Completed

Conditions: Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01879436

0053-13-MMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Placentae that were destroyed during pregnancy termination.

Trial design

100 participants in 2 patient groups

Pregnant women

Description:

Women during first trimester of pregnancy (age: 18-45) Group contain 50 healthy pregnant women, age 18-45. Sera will be taken from: 1. the same branula that will be introduced into the pregnant women as a routine during pregnancy termination procedure.2. from the vein of volunteered pregnant women which do not terminate pregnancy. First trimester placenta will be collected after pregnancy termination. 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) Investigators will not treat the women with any drug.

Non pregnant women

Description:

Group contain 50 healthy women, age 18-45. Sera will be taken from the vein of the volunteered women. Investigators will not treat the women with any drug.