Nicotine's Effect on Cancer Stem Cell Markers in Human Umbilical Cord Tissue

January 24, 2025 updated by: Celal Bayar University

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

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mani̇sa
      • Manisa, Mani̇sa, Turkey, 45030
        • Hayrunnisa yeşil Sarsmaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

pregnant women smokers pregnant women nonsmokers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1:
smokers
Group 2:
nonsmokers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

December 5, 2024

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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