CancerNCT01879436
The Effect of Human Placental Explants and Pregnant Women Sera on Cancer Cells
An observational study of Cancer, run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women Age 18-45. Pregnant (6-9 weeks) and non pregnant women.
Who may be able to join
- Healthy women
- Age 18-45.
- Pregnant (6-9 weeks) and non pregnant women.
Who cannot join
- Placentae that were destroyed during pregnancy termination.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cancer
- Keywords
- Pregnancy, Placenta, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 24 hours and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lishner, MD, Principal investigator, Meor Medical Center, Kfar-Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879436
- Sponsor's protocol ID
- 0053-13-MMC
- Status last verified
- Oct 2020
- First submitted
- 10 Jun 2013
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20719812
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Human Placental Explants and Pregnant Women Sera on Cancer Cells
- ClinicalTrials.gov ID
- NCT01879436
- Acronym / sponsor ID
- 0053-13-MMC
- Conditions
- Cancer
- Keywords
- Pregnancy, Placenta, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women Age 18-45. Pregnant (6-9 weeks) and non pregnant women.
Key inclusion criteria (3 listed)
- Healthy women
- Age 18-45.
- Pregnant (6-9 weeks) and non pregnant women.
Key exclusion criteria (1 listed)
- Placentae that were destroyed during pregnancy termination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer cell phenotype (in the laboratory)
Time frame: Baseline, 24 hours and 72 hours
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 20719812Tartakover-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lishner, MD principal investigator
Meor Medical Center, Kfar-Saba, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer cell phenotype (in the laboratory) (time frame: Baseline, 24 hours and 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.