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
1 other identifier
observational
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2024
CompletedJanuary 27, 2025
January 1, 2025
2.5 years
November 5, 2024
January 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline
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.
Baseline
Study Arms (2)
Group 1:
smokers
Group 2:
nonsmokers
Eligibility Criteria
pregnant women smokers pregnant women nonsmokers
You may qualify if:
- Healthy pregnancy under 37 weeks
- Age range 18-50
- Being literate in Turkish
- Not having any additional disease
- Agreeing to participate in the study
You may not qualify if:
- 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
- Premature birth of patients included in the control group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hayrunnisa yeşil Sarsmaz
Manisa, Mani̇sa, 45030, Turkey (Türkiye)
Biospecimen
umblical cord tissues and blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2024
First Posted
November 7, 2024
Study Start
January 14, 2017
Primary Completion
July 1, 2019
Study Completion
December 5, 2024
Last Updated
January 27, 2025
Record last verified: 2025-01