EndometriosisPROTEO-ENDONCT06214260
Menstrual Blood Proteomic Profile in Women With Endometriosis (PROTEO-ENDO) Study
An observational study of Endometriosis and Endometriosis Ovary, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In this prospective case control study a total of 66 women (33 women with endometriosis) and (33 healthy women) will be recruited. The main objective of the study is to investigate the proteomic profile of menstrual blood in women with endometriosis compared to controls. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Endometriosis Ovary, Endometriosis-related Pain
- What is being tested?
- Peripheral blood sample and Menstrual Blood sample
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Nov 2023to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Endometriosis group: Patients referred to Obstetrics and Gynaecology specialty outpatient clinic by clinicians for the diagnosis of endometriosis, and/or treatment, or for pelvic pain investigation, and agreed to undergo for laparoscopic surgery for the investigation and/or treatment of endometriosis, or pelvic pain will be recruited. Healthy groups: Women who have self-reported that they do not have any known medical, surgical, or gynecological conditions.
Who may be able to join
- Endometriosis group. are women aged 18-45 years old Laparoscopy with histologically confirmed diagnosis of endometriosis
- Healthy group are women between 18-45 years old self reported no known history of medical \& surgical diseases and no any sign of endometriosis related symptoms
Who cannot join
- Endometriosis group
- Hormonal treatment in the past three months before surgery,
- Previous and current malignancy
- Having history of autoimmune disease
- Having previous surgery due to endometriosis
- Pelvic inflammatory disease (PID)
Show all 20Show fewer
- Lactating/breastfeeding women
- Adenomyosis
- Polycystic ovarian syndrome (PCOS)
- History of or currently on traditional Chinese medicine
- Healthy group
- Hormonal treatment in the past three months before surgery,
- Previous and current malignancy
- Having history of autoimmune disease
- Having previous surgery due to endometriosis
- Pelvic inflammatory disease (PID)
- Lactating/breastfeeding women
- Adenomyosis
- Polycystic ovarian syndrome (PCOS)
- History of or currently on traditional Chinese medicine
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong
Chi Chiu Wang, MD, PhD, (852) 35054267, ccwang@cuhk.edu.hk
Getnet Gedefaw Azeze, Msc, 852 5172 4303, gedefawget@link.cuhk.edu.hk
About this study
Official title: Proteomic Profile in Women With Endometriosis (PROTEO-ENDO) Study
In this prospective case control study a total of 66 women (33 women with endometriosis) and (33 healthy women) will be recruited. The main objective of the study is to investigate the proteomic profile of menstrual blood in women with endometriosis compared to controls. Additionally, differentially expressed proteins will be investigated across different stages, clinical presentations, and subtypes of endometriosis
Read the detailed description
Endometriosis is a disease characterized by the growth of endometrium like tissue outside the uterus. It is the most common and complex gynecological complications in reproductive age woman and schoolgirls. Though the exact etiology of endometriosis is unknown, and the incidence is varying among age and women with infertility, however, it ranges from 2% to 10% within the general female population, estimating around 190 million women at reproductive age and schoolgirls globally and up to 50% in infertile women. The variable, non-specific and broad symptoms of endometriosis lead the clinicians not to easily diagnose the disease and it causes a lengthy delay between the onset of symptoms and confirmation of diagnosis. To date, there is no known non-invasive diagnostic method for endometriosis and no known cure for endometriosis, and treatment is usually aimed at controlling symptoms. New noninvasive non-imaging diagnostic methods, such as biomarkers in serum/blood, and urine have been proposed. However, a definitive diagnosis biomarker is not available yet. Despite the range of blood tests that have been investigated, and altered levels of cancer antigen (CA-125), cytokines, angiogenic, and growth factors, none of the biomarkers showed the definitive diagnosis of endometriosis. Hence this prospective case control study aims to explore non-invasive diagnostic biomarkers from menstrual blood and establish pathophysiology mechanism of the disease. This study is undergoing based on the Helsinki Declaration Guideline for Good Clinical Practice (GCP) standards. Ethical approval is obtained from the Joint Chinese University of Hong Kong and New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee, Hong Kong with reference number: 2023.126.
- Being tested
- Peripheral blood sample, Menstrual Blood sample
- Keywords
- Endometriosis, Menstrual blood, Proteomics
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood sampleDiagnostic test
Peripheral blood will be collected with a 10 ml Ethylenediaminetetra acetic acid (EDTA) tube before surgery during menstrual phase. Additionally, participants will be asked with an interview on demographic, surgical, medical, obstetric, gynecological, contraceptive and medication use history which is validated by Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project (WERF EPHect). Pain symptoms before surgery will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS).
Menstrual Blood sampleDiagnostic test
5ml menstrual blood will be collected before surgery by the women herself. Additionally, participants will be asked with an interview on demographic, surgical, medical, obstetric, gynecological, contraceptive and medication use history which is validated by Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project (WERF EPHect). Pain symptoms before surgery will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS).
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Women suggested endometriosis by clinical presentations \& imaging and scheduled for surgical treatment (laparotomy/laparoscopy) at the age of 18-45 years having regular menstrual cycles will be recruited. Finally laparoscopy and histology confirmed endometriosis cases will be eligible for the final analysis. Receives: Diagnostic Test: Peripheral blood sample; Diagnostic Test: Menstrual Blood sample | |
| Healthy groups | Control subjects at the age of 18-45 years, who have regular menstrual cycles and self-reported no history suggestive of a diagnosis of endometriosis will be recruited. Receives: Diagnostic Test: Peripheral blood sample; Diagnostic Test: Menstrual Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual blood plasma proteomic profile using Liquid chromatography-mass spectrometry (LC-MS/MS)
A functional proteomic assay will be employed to separate a protein to identify the putative novel biomarkers of endometriosis using shotgun proteomics with mass spectrometry. Both expression and functional proteomics will be investigated in women with endometriosis, and controls. A bottom-up proteomics approach will be implemented through steps such as extraction of proteins from a sample, digestion of proteins into peptides, post-digestion separations, and analysis
Measured: 24 months
Secondary outcomes (3)
Determination of menstrual blood plasma proteomic profile in endometriosis phenotypes using an LC-MS/MS
Investigators expect that women in the endometriosis group will differ with regard to proteomic profile with respect to the disease phenotype different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis
Measured: 24 months
Menstrual blood plasma proteomic profile in early (stage I/II) and Advance (stage III/IV) stage of endometriosis
According to the revised American society of reproductive medicine (rASRM) endometriosis is categorized in to four stages. The protein expression of each stages of endometriosis will be compared with the bottom-up approach proteomics study using LC-MS/MS
Measured: 24 months
Comparing the plasma of menstrual and peripheral blood proteomic profile using LC-MS/MS
As the composition of menstrual blood is heterogeneous and complex, investigators expect the expressed proteins from the peripheral blood plasma will differ from the expressed proteins of menstrual blood.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Nov 2023
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Wang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214260
- Sponsor's protocol ID
- PROTEO-ENDO 20230313
- Acronym
- PROTEO-ENDO
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available as a supplementary file in publications. It will be available to anyone up on the official request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Profile in Women With Endometriosis (PROTEO-ENDO) Study
- ClinicalTrials.gov ID
- NCT06214260
- Acronym / sponsor ID
- PROTEO-ENDO / PROTEO-ENDO 20230313
- Keywords
- Endometriosis, Menstrual blood, Proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective case control study a total of 66 women (33 women with endometriosis) and (33 healthy women) will be recruited. The main objective of the study is to investigate the proteomic profile of menstrual blood in women with endometriosis compared to controls. Additionally, differentially expressed proteins will be investigated across different stages, clinical presentations, and subtypes of endometriosis
Detailed description
Endometriosis is a disease characterized by the growth of endometrium like tissue outside the uterus. It is the most common and complex gynecological complications in reproductive age woman and schoolgirls. Though the exact etiology of endometriosis is unknown, and the incidence is varying among age and women with infertility, however, it ranges from 2% to 10% within the general female population, estimating around 190 million women at reproductive age and schoolgirls globally and up to 50% in infertile women. The variable, non-specific and broad symptoms of endometriosis lead the clinicians not to easily diagnose the disease and it causes a lengthy delay between the onset of symptoms and confirmation of diagnosis. To date, there is no known non-invasive diagnostic method for endometriosis and no known cure for endometriosis, and treatment is usually aimed at controlling symptoms. New noninvasive non-imaging diagnostic methods, such as biomarkers in serum/blood, and urine have been proposed. However, a definitive diagnosis biomarker is not available yet. Despite the range of blood tests that have been investigated, and altered levels of cancer antigen (CA-125), cytokines, angiogenic, and growth factors, none of the biomarkers showed the definitive diagnosis of endometriosis. Hence this prospective case control study aims to explore non-invasive diagnostic biomarkers from menstrual blood and establish pathophysiology mechanism of the disease. This study is undergoing based on the Helsinki Declaration Guideline for Good Clinical Practice (GCP) standards. Ethical approval is obtained from the Joint Chinese University of Hong Kong and New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee, Hong Kong with reference number: 2023.126.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Diagnostic Test: Peripheral blood sample, Diagnostic Test: Menstrual Blood sampleWomen suggested endometriosis by clinical presentations \& imaging and scheduled for surgical treatment (laparotomy/laparoscopy) at the age of 18-45 years having regular menstrual cycles will be recruited. Finally laparoscopy and histology confirmed endometriosis cases will be eligible for the final analysis. |
| Healthy groups | – | Diagnostic Test: Peripheral blood sample, Diagnostic Test: Menstrual Blood sampleControl subjects at the age of 18-45 years, who have regular menstrual cycles and self-reported no history suggestive of a diagnosis of endometriosis will be recruited. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Endometriosis group: Patients referred to Obstetrics and Gynaecology specialty outpatient clinic by clinicians for the diagnosis of endometriosis, and/or treatment, or for pelvic pain investigation, and agreed to undergo for laparoscopic surgery for the investigation and/or treatment of endometriosis, or pelvic pain will be recruited. Healthy groups: Women who have self-reported that they do not have any known medical, surgical, or gynecological conditions.
Key inclusion criteria (2 listed)
- Endometriosis group. are women aged 18-45 years old Laparoscopy with histologically confirmed diagnosis of endometriosis
- Healthy group are women between 18-45 years old self reported no known history of medical \& surgical diseases and no any sign of endometriosis related symptoms
Key exclusion criteria (20 listed)
- Endometriosis group
- Hormonal treatment in the past three months before surgery,
- Previous and current malignancy
- Having history of autoimmune disease
- Having previous surgery due to endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood samplePeripheral blood will be collected with a 10 ml Ethylenediaminetetra acetic acid (EDTA) tube before surgery during menstrual phase. Additionally, participants will be asked with an interview on demographic, surgical, medical, obstetric, gynecological, contraceptive and medication use history which is validated by Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project (WERF EPHect). Pain symptoms before surgery will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS). | Diagnostic test | Endometriosis, Healthy groups |
| Menstrual Blood sample5ml menstrual blood will be collected before surgery by the women herself. Additionally, participants will be asked with an interview on demographic, surgical, medical, obstetric, gynecological, contraceptive and medication use history which is validated by Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project (WERF EPHect). Pain symptoms before surgery will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS). | Diagnostic test | Endometriosis, Healthy groups |
Primary outcome
Menstrual blood plasma proteomic profile using Liquid chromatography-mass spectrometry (LC-MS/MS)
Time frame: 24 months
A functional proteomic assay will be employed to separate a protein to identify the putative novel biomarkers of endometriosis using shotgun proteomics with mass spectrometry. Both expression and functional proteomics will be investigated in women with endometriosis, and controls. A bottom-up proteomics approach will be implemented through steps such as extraction of proteins from a sample, digestion of proteins into peptides, post-digestion separations, and analysis
3 secondary outcomes
Determination of menstrual blood plasma proteomic profile in endometriosis phenotypes using an LC-MS/MS
Time frame: 24 months
Menstrual blood plasma proteomic profile in early (stage I/II) and Advance (stage III/IV) stage of endometriosis
Time frame: 24 months
Comparing the plasma of menstrual and peripheral blood proteomic profile using LC-MS/MS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Yes. Individual participant data will be available as a supplementary file in publications. It will be available to anyone up on the official request from the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Endometriosis Ovary, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi Chiu Wang, MD, PhD ((852) 35054267, ccwang@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual blood plasma proteomic profile using Liquid chromatography-mass spectrometry (LC-MS/MS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.