- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06678152
Nicotine's Effect on Cancer Stem Cell Markers in Human Umbilical Cord Tissue
Investigation of Nicotine in Umbilical Cord Tissue: Immunohistochemical and Biochemical Analysis of Cancer Stem Cell Markers
The umbilical cord is generally an organ that clinicians and pathologists do not pay sufficient attention to. The absence of significant pathology in the umbilical cords, along with the lack of association between certain placental pathologies and perinatal mortality and morbidity, have led both clinicians and pathologists to inadequately evaluate the placenta and umbilical cord. In our study, İnvestigators aimed to perform immunohistochemical and biochemical analysis by comparing two groups, one consisting of women who smoked throughout their pregnancy and the other of those who never smoked, including different markers in accordance with the literature.
Method: The pregnant women included in the study were categorized according to their smoking status as follows:
Group I: Non-smokers (smoking -) Group II: Smokers (smoking +) during pre-pregnancy and throughout the pregnancy In this study, 40 pregnant women who smoked during their pregnancy (between 37 and 42 weeks of gestation) and 37 age- and parity-matched healthy non-smoking pregnant women with full-term births between 37 and 42 weeks of gestation were selected as the control group. Umbilical cord samples (2 ml of blood and a 5 cm tissue sample) were collected from both groups without delay and fixed in 10% formalin. The tissue samples were processed for histological analysis with routine hematoxylin and eosin (H&E) staining following fixation in 10% formalin solution and routine paraffin embedding.
İnvestigators aimed to examine the presence of oncological factors such as CD44, CD34, CD90, and ALDH molecules in the umbilical cord tissue of smokers during pregnancy through immunohistochemistry, and to explore the biochemical relationship of these molecules with their counterparts, CD34, CD44, CD90, and ALDH, found in the umbilical cord blood.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mani̇sa
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Manisa, Mani̇sa, Turkey, 45030
- Hayrunnisa yeşil Sarsmaz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy pregnancy under 37 weeks
- Age range 18-50
- Being literate in Turkish
- Not having any additional disease
- Agreeing to participate in the study
Exclusion Criteria:
- High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
- Multiple pregnancy
- Pregnant women under the age of 18
- Smoking
- Medication use (excluding routinely used food supplements during pregnancy)
- Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
- Immunosuppressive use
- Presence of active or chronic infection
- Presence of active or chronic inflammatory disease
- Patients who gave birth at an external center or later chose to withdraw from the study
- Patients who did not have any exclusion criteria at the time of smokers or when blood was drawn for the control group, but who later developed any exclusion criteria.
- Premature birth of patients included in the control group
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1:
smokers
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Group 2:
nonsmokers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Hospitalized pregnant women's with smokers and nonsmokers 80%umblical cord tissues 3x3 cm collected while birth during the study .umblical tissues staining will be Measured by Cd34, Cd44, Cd90 and ALDH immunohistochemistry technique.
Time Frame: Baseline
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Baseline
|
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Hospitalized pregnant women's with smokers and nonsmokers 80% umblical blood 5-7 ml collected while birth during the study. Bloods will be measured by Cd34, Cd44, Cd90 and ALDH biochemistry elisa technique.
Time Frame: Baseline
|
Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCBU_ Nicotin_cancer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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