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

NCT01879436 | Completed DMC

• 1 other identifier: 0053-13-MMC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Pregnancy, Placenta, Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Placentae that were destroyed during pregnancy termination.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Oncogenetic Laboratory, Meir Medical Center

Kfar Saba, Israel

Location

Related 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.

  PMID: 20719812 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Placentae will be collected and used in cell culture experiments for a week. Their proteins and RNA will be analyzed.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michael Lishner, MD

  Meor Medical Center, Kfar-Saba, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 17, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

IL (1)