Metabolomic Profile in Women With and Without Endometriosis

NCT05496218 | Unknown

• 1 other identifier: 0009220 U
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The pathogenesis of endometriosis is very complex as several factors, including genetic, environmental and lifestyle-related factors, are involved in the development, progression and maintenance of the disease. In particular, there are emerging evidences that prostaglandin metabolism, chronic inflammatory processes and circulating estrogen levels are involved in the pathogenesis of endometriosis. Pelvic pain, in particular dysmenorrhea, is the most typical symptom caused by the production of prostaglandins and pain mediators associated with the peritoneal inflammatory state. Metabolomics strives to measure all metabolites, such as sugars, amino acids, acylcarnitines, organic acids, and lipids, present in a given biological sample. Thus, metabolomics represents a reflection of phenotypic changes in an organism in response to the presence of a certain disease, genetic changes, and nutritional, toxicological, environmental, and pharmacological influences, providing a means to more accurately capture exogenous exposures and evaluate endogenous biomarkers. Regarding endometriosis, the targeted metabolomics studies focused mainly on lipids, and the non-targeted studies also identified mainly lipids, amino acids, and intermediary metabolites as the most important variables. The combinations of metabolomics data together with clinical ones are of utmost importance in endometriosis research. This approach might lead to the construction of models/algorithms useful to better define diagnostic/prognostic characteristics of women who have endometriosis, identify environmental and modifiable risk factors, elucidate pathogenetic mechanisms, and contribute to better tailor medical treatments. In particular, metabolomics may provide a means to capture exogenous exposures and evaluate endogenous biomarkers more accurately. The main objective of the present research project is to evaluate potential variations in the plasma metabolomic profile of women affected by endometriosis (as compared with a control group) as a consequence of pathophysiologic alterations associated with this disorder. Secondary objectives are:

1. 1.to evaluate potential variations in the plasma metabolomic profile of endometriosis patients with different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis;
2. 2.to evaluate potential variations in the plasma metabolomic profile of endometriosis patients in relation to the presence of endometriosis-related painful symptoms and/or infertility.

Conditions

Endometriosis; Endometriosis-related Pain; Infertility

Keywords

Metabolomics; Personalized medicine; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Determination of plasma metabolomic profile using an LC-MS/MS targeted metabolomic method

  Potential variations in the plasma metabolomic profile of endometriosis patients as a consequence of pathophysiologic alterations associated with this disorder. Metabolomic set-up will be evaluated with a targeted approach and instrumentation based on the triple quadrupole mass Spectrometry interfaced with liquid chromatography at very high pressure. Metabolomic profile analysis of subjects will be conducted using a targeted LC-MS/MS metabolomic method through the AbsoluteIDQ kit¹ p180. A good inter-laboratory reproducibility of this test was reported for measurements of the above metabolites in human plasma. The instrumentation will consist of a high pressure liquid chromatograph Agilent coupled with hybrid triple quadrupole/linear ion trap mass spectrometer with an electrospray ionization source. The test shall be conducted according to the manufacturer's instructions.

  24 months

Secondary Outcomes (4)

• Relation between Plasma metabolomic profile and endometriosis phenotypes through a questionnaire

  24 months

• Plasma metabolomic profile and fertility in terms of pregnancy rate

  24 months

• Relation between Plasma metabolomic profile and pelvic pain evaluated through visual-analogue scale (VAS)

  24 months

• Plasma metabolomic profile and dietary exposure through food frequency questionnaire (FFQ)

  24 months

Study Arms (2)

Endometriosis group

EXPERIMENTAL

Endometriosis group are women aged 18-45 with a histologically confirmed diagnosis of endometriosis. At study entry, we will collect morning blood samples.

Diagnostic Test: Blood samples

Control Group

EXPERIMENTAL

Control group are women aged 18-45 surgically verified not to have endometriosis. At study entry, we will collect morning blood samples.

Diagnostic Test: Blood samples

Interventions

Blood samples DIAGNOSTIC_TEST

At study entry, we will collect morning blood samples from fasting women. participants will be asked with an interview on demographic and lifestyle characteristics, health-related behaviours, the existence and duration of infertility, medical history, and history of hormonal or surgical treatments for endometriosis. Pain symptoms before surgery will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS). In addition, women will be asked to report about their usual weekly food consumption in the previous year. Information on the diet will be based on a reproducible and valid food frequency questionnaire. Energy and mineral and macro-and micronutrient intakes will be estimated using the most recent update of an Italian Food Consumption Database.

Control Group; Endometriosis group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Endometriosis group.
• are women aged 18-45
• histologically confirmed diagnosis of endometriosis consecutively observed at the "Endometriosis center" Fondazione IRCCS Ospedale Maggiore Policlinico, Milan.
• Only incident cases (i.e. diagnosis within three months before study entry) will be eligible.
• Control group are women aged 18-45 surgically verified not to have endometriosis. In this group, the indications for surgery will be abdominal surgical emergencies, tubal infertility, non-endometriotic ovarian cysts, or uterine fibroids. Controls will be identified consecutively at the same institution where cases have been identified.

You may not qualify if:

• Endometriosis group:
• the presence of diseases causing pelvic pain other than endometriosis,
• hormonal treatment in the past two months before surgery,
• menopausal state
• pregnancy
• gynecological cancers
• pelvic inflammatory disease
• Control group:
• hormonal treatment in the past two months before surgery
• menopausal state
• pregnancy
• gynecological cancers.
• pelvic inflammatory disease

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis; Infertility; Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paolo Vercellini, Prof.

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Vercellini, Prof.

CONTACT

0255032318; paolo.vercellini@unimi.it

Laura Buggio, MD

CONTACT

0255032318; laura.buggio@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Study participants will be subjected to blood sampling that is not part of the routine clinical practice, so it's an interventional study.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-center case-control study.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: August 11, 2022
• Study Start: April 9, 2022
• Primary Completion: October 31, 2023
• Study Completion: February 28, 2024
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)