Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of M1 and M2 Macrophages in Endometriotic Tissue of Women Affected by Endometriosis at Different Stages.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03136978
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
University of Ljubljana
University of Padova
Information provided by (Responsible Party):
Antonio Simone Laganà, University of Messina

Brief Summary:

Accumulating evidence suggests that the peritoneal microenvironment of women affected by endometriosis undergoes a number of local inflammatory-reparative phenomena, with the involvement of resident macrophages, and the attraction and recruitment of peripheral mononuclear cells (monocytes and lymphocytes) from the blood into the peritoneal cavity: during endometriosis a breakdown occurs in endometrial and peritoneal homeostasis caused by cytokine-addressed cell proliferation and dysregulation of apoptosis.

The surrounding microenvironment may address the macrophage plasticity towards a transient and reversible polarization. These polarized phenotypes reflects the proinflammatory or anti-inflammatory status and may change over the time. They could be functionally classified in two main populations: "classically activated" macrophages (M1) and "alternatively activated" macrophages (M2).

Considering that published data so far are still not robust enough to drawn firm conclusion, the aim of this research project will be to evaluate M1 and M2 macrophages in endometriotic tissue from women affected by endometriosis at different stages.


Condition or disease Intervention/treatment
Endometriosis Diagnostic Test: Evaluation of M1 and M2 macrophages by flow cytometry.

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Evaluate M1 and M2 Macrophages in Endometriotic Tissue of Women Affected by Endometriosis at Different Stages.
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Endometriosis
Patients affected by endometriosis (histologically confirmed) at different stages, who will undergo laparoscopic surgery.
Diagnostic Test: Evaluation of M1 and M2 macrophages by flow cytometry.
To assess surface expression of macrophage markers, tissue samples will be stained for flow cytometry with fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CCR7 and CD80 to identify M1, whereas fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CD163 and CD206 to identify M2.

Ovarian functional cysts
Patients affected by ovarian functional cysts, who will undergo laparoscopic surgery.
Diagnostic Test: Evaluation of M1 and M2 macrophages by flow cytometry.
To assess surface expression of macrophage markers, tissue samples will be stained for flow cytometry with fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CCR7 and CD80 to identify M1, whereas fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CD163 and CD206 to identify M2.




Primary Outcome Measures :
  1. Quantification of M1 and M2 macrophages in endometriotic tissue for each stage of endometriosis. [ Time Frame: Day 1 ]
    To assess surface expression of macrophage markers, endometrial tissue cells will be stained for flow cytometry with fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CCR7 and CD80 to identify M1, whereas fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CD163 and CD206 to identify M2.


Secondary Outcome Measures :
  1. Correlation of M1 and M2 macrophages quantity in endometriotic tissue to the presence of endometriosis-associated infertility. [ Time Frame: Day 1 ]
    To assess surface expression of macrophage markers, endometrial tissue cells will be stained for flow cytometry with fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CCR7 and CD80 to identify M1, whereas fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CD163 and CD206 to identify M2. Female infertility will be defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse.

  2. Correlation of M1 and M2 macrophages quantity in endometriotic tissue to the presence of endometriosis-associated chronic pelvic pain. [ Time Frame: Day 1 ]
    To assess surface expression of macrophage markers, endometrial tissue cells will be stained for flow cytometry with fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CCR7 and CD80 to identify M1, whereas fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CD163 and CD206 to identify M2. Chronic pelvic pain will be defined as pain that occurs below the umbilicus (belly button) that lasts for at least six months.


Biospecimen Retention:   Samples Without DNA
  • Endometriotic tissue (histologically confirmed) from patients affected by endometriosis at different stages (cases).
  • Tissue samples from ovarian functional cysts (controls).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Reproductive-aged patients affected by histologically confirmed endometriosis (cases) and by ovarian functional cysts (controls), who will undergo laparoscopic surgery.
Criteria

Inclusion Criteria:

  • Patients affected by histologically confirmed endometriosis (cases)
  • Patients affected by ovarian function cysts (controls)

Exclusion Criteria:

  • Other pelvic disorders (apart ovarian functional cysts)
  • Chronic circulatory disorders
  • Autoimmune disorders
  • Neoplastic disorders
  • Patients who were treated with any anti-inflammatory or hormonal or immunomodulatory medication in the preceding 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136978


Locations
Layout table for location information
Italy
University of Messina
Messina, Italy, 98122
Sponsors and Collaborators
University of Messina
University of Ljubljana
University of Padova
Investigators
Layout table for investigator information
Principal Investigator: Antonio Simone Laganà, M.D. University of Messina
Publications:

Layout table for additonal information
Responsible Party: Antonio Simone Laganà, Principal Investigator, University of Messina
ClinicalTrials.gov Identifier: NCT03136978    
Other Study ID Numbers: ENDOMAC
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Simone Laganà, University of Messina:
Macrophages
Macrophages, Peritoneal
Endometriosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis