Alterations in Mast Cell and Macrophage Infiltration, as Well as Micro Vessel Density

September 1, 2026 updated by: Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt

Understanding Alterations in Mast Cell and Macrophage Infiltration, as Well as Micro Vessel Density, May Throw Light on the Early Events Leading to Gastric Carcinogenesis in Obesity

Obesity is a global health problem that has reached epidemic proportions, affecting more than one billion people worldwide and significantly increasing the risk of multiple comorbidities, including type 2 diabetes, cardiovascular diseases, and cancer (World Health Organization, 2024). Increasing evidence suggests that chronic low-grade inflammation associated with obesity plays a critical role in the development of obesity-related malignancies, including gastric cancer. Adipose tissue dysfunction in obesity leads to the recruitment and activation of various immune cells, such as macrophages and mast cells, which contribute to a pro-inflammatory microenvironment through the release of cytokines, growth factors, and angiogenic mediators.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

In the gastric mucosa, this inflammatory micro environment associated with obesity may promote epithelial proliferation, DNA damage, and neovascularization, establishing conditions favorable for early carcinogenic transformation. Mast cells presence at the periphery and infiltrating tumors, argues for their role in the modulation of tumor biology it has been implicated in tumor progression through their ability to release histamine, tryptase, and vascular endothelial growth factor (VEGF), thereby enhancing angiogenesis and stromal remodeling. Similarly, macrophages especially those exhibiting an M2-like phenotype can facilitate tissue remodeling and angiogenesis, further supporting tumor initiation. The number and phenotype of macrophages vary at different stages of tumor progression. The number of macrophages markedly increases during the early stages of tumor growth.

Despite the growing recognition of the link between obesity, inflammation, and cancer, few studies have explored the immunopathological changes occurring in the gastric mucosa of obese patients before overt malignancy. Bariatric surgery provides a unique opportunity to study these changes in human gastric tissue. Understanding alterations in mast cell and macrophage infiltration, as well as microvessel density, may throw light on the early events leading to gastric carcinogenesis in obesity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • Egypt
    • Alexandria Governorate
      • Alexandria, Alexandria Governorate, Egypt, 21531
        • The surgical department of Medical Research Institute Hospital, Alexandria University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Fifty gastric tissue samples will be collected from patients with obesity undergoing bariatric surgery and fifty from lean control patients undergoing endoscopic biopsy for benign or malignant gastric conditions. All participants underwent preoperative evaluation including blood tests.

All patients were evaluated by a multidisciplinary team consisting of a nutritionist, psychiatrist, endocrinologist, radiologist, anesthesiologist, and surgeon. Endocrinologic assessment excluded secondary causes of obesity (e.g., Cushing's syndrome, polycystic ovary syndrome). Only patients with a body mass index (BMI) > 35 kg/m² were included. All surgical procedures were laparoscopic sleeve gastrectomies (LapSG).

Description

Inclusion Criteria:

  • Adult patients undergoing bariatric surgery (laparoscopic sleeve gastrectomy).
  • BMI > 35 kg/m²
  • All participants underwent preoperative evaluation, including blood tests and assessment by a multidisciplinary team (nutritionist, psychiatrist, endocrinologist, radiologist, anesthesiologist, and surgeon).

Exclusion Criteria:

  • Patients with secondary causes of obesity, such as Cushing's syndrome or polycystic ovary syndrome (PCOS).
  • Patients with malignant gastric conditions or previous gastric surgery.
  • Patients with systemic inflammatory diseases, autoimmune disorders, or chronic infections that may influence immune cell infiltration.
  • Patients with incomplete clinical data or poor-quality tissue samples.
  • Patients taking anti-inflammatory, immunosuppressive, or corticosteroid therapy within the last 3 months before sampling.

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 / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with obesity undergoing bariatric surgery
Procedure: bariatric surgery laparoscopic sleeve gastrectomy

Adipose tissue macrophages (ATMs), mast cells positive for tryptase (MCPT), and microvascular density (MVD) were assessed by immunohistochemistry.

Quantitative assessment was performed using a light microscope. For each GTO and NT tissue section, five highly immunostained areas ("hot spots") were identified at low magnification.
lean control patients undergoing endoscopic biopsy for benign or malignant gastric conditions
Procedure: lean control patients undergoing endoscopic biopsy for benign or malignant gastric conditions.

Adipose tissue macrophages (ATMs), mast cells positive for tryptase (MCPT), and microvascular density (MVD) were assessed by immunohistochemistry.

Quantitative assessment was performed using a light microscope. For each GTO and NT tissue section, five highly immunostained areas ("hot spots") were identified at low magnification.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immunohistochemistry
Time Frame: Baseline

Compare the 2 groups:

Adipose tissue macrophages (ATMs) was assessed by immunohistochemistry using a three-step biotin-avidin-peroxidase detection method. five-micrometer-thick serial sections were cut from formalin-fixed, paraffin-embedded gastric tissue of obese (GTO) and control normal tissue (NT) samples. Antigen retrieval was performed using a microwave oven (500 W for 10 minutes), followed by endogenous peroxidase blocking with a 3% hydrogen peroxide solution.

Slides were incubated with the following primary antibodies for 1 hour at room temperature:

  • Anti-tryptase (clone AA1; Dako, Glostrup, Denmark; 1:100) for mast cell identification,
  • Anti-CD68 (clone KP1; Dako, Glostrup, Denmark; 1:100) for ATM detection,
  • Anti-CD31 (clone QB-END 10; Bio-Optica, Milan, Italy; 1:50) as a pan-endothelial marker to assess MVD.
Baseline
Immunohistochemistry
Time Frame: Baseline

Compare the 2 groups:

Mast cells positive for tryptase (MCPT) was assessed by immunohistochemistry using a three-step biotin-avidin-peroxidase detection method. five-micrometer-thick serial sections were cut from formalin-fixed, paraffin-embedded gastric tissue of obese (GTO) and control normal tissue (NT) samples. Antigen retrieval was performed using a microwave oven (500 W for 10 minutes), followed by endogenous peroxidase blocking with a 3% hydrogen peroxide solution.

Slides were incubated with the following primary antibodies for 1 hour at room temperature:

  • Anti-tryptase (clone AA1; Dako, Glostrup, Denmark; 1:100) for mast cell identification,
  • Anti-CD68 (clone KP1; Dako, Glostrup, Denmark; 1:100) for ATM detection,
  • Anti-CD31 (clone QB-END 10; Bio-Optica, Milan, Italy; 1:50) as a pan-endothelial marker to assess MVD.
Baseline
Immunohistochemistry
Time Frame: Baseline

Compare the 2 groups:

Microvascular density (MVD) was assessed by immunohistochemistry using a three-step biotin-avidin-peroxidase detection method. five-micrometer-thick serial sections were cut from formalin-fixed, paraffin-embedded gastric tissue of obese (GTO) and control normal tissue (NT) samples. Antigen retrieval was performed using a microwave oven (500 W for 10 minutes), followed by endogenous peroxidase blocking with a 3% hydrogen peroxide solution.

Slides were incubated with the following primary antibodies for 1 hour at room temperature:

  • Anti-tryptase (clone AA1; Dako, Glostrup, Denmark; 1:100) for mast cell identification,
  • Anti-CD68 (clone KP1; Dako, Glostrup, Denmark; 1:100) for ATM detection,
  • Anti-CD31 (clone QB-END 10; Bio-Optica, Milan, Italy; 1:50) as a pan-endothelial marker to assess MVD.
Baseline
Morphometric Analysis
Time Frame: Baseline

Compare the 2 groups:

Quantitative assessment was performed using a light microscope. For GTO tissue section, five highly immunostained areas ("hot spots") were identified at low magnification. ATMs, MCPT, and MVD were then quantified at ×40 magnification. The mean value across five hot spots per marker was used for each sample.

To evaluate mast cell degranulation, the presence of tryptase-positive granules in the extracellular matrix was examined. Degranulating mast cells were identified by the diffusion of immunoreactive granules outside the cell boundaries, indicating active release of tryptase. This extracellular localization of tryptase provided morphological evidence of mast cell activation and was considered a marker of tissue inflammation and remodeling.
Baseline
Morphometric analysis
Time Frame: Baseline

Compare the 2 groups:

Quantitative assessment was performed using a light microscope. For NT tissue section, five highly immunostained areas ("hot spots") were identified at low magnification. ATMs, MCPT, and MVD were then quantified at ×40 magnification. The mean value across five hot spots per marker was used for each sample.

To evaluate mast cell degranulation, the presence of tryptase-positive granules in the extracellular matrix was examined. Degranulating mast cells were identified by the diffusion of immunoreactive granules outside the cell boundaries, indicating active release of tryptase. This extracellular localization of tryptase provided morphological evidence of mast cell activation and was considered a marker of tissue inflammation and remodeling.
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General Committee of Teaching Hospitals and Institutes, Egypt

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mast cells obesity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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