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

NCT ID: NCT06678152

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-14
• Study Completion Date: 2024-12-05

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.

Conditions

Umbilical Cord Issue; Nicotine Addiction; Pregnancy Related; Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1:

smokers

No interventions assigned to this group

Group 2:

nonsmokers

No interventions assigned to this group

Eligibility Criteria

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
• Premature birth of patients included in the control group

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Celal Bayar University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hayrunnisa yeşil Sarsmaz

Manisa, Mani̇sa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MCBU_ Nicotin_cancer

Identifier Type: -

Identifier Source: org_study_id