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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Pregnant women

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.

No interventions assigned to this group

Non pregnant women

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• Placentae that were destroyed during pregnancy termination.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Lishner, MD

Role: PRINCIPAL_INVESTIGATOR

Meor Medical Center, Kfar-Saba, Israel

Locations

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Oncogenetic Laboratory, Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND

PMID: 20719812 (View on PubMed)

Other Identifiers

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0053-13-MMC

Identifier Type: -

Identifier Source: org_study_id