EndometriosisNCT06298617
Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis
An observational study of Endometriosis, run by Benha University at 1 site in Egypt.
Trial summary
Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Diagnostic laparoscopy and Full Blood Count (FBC)
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 25 Dec 2023
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All women attending the outpatient of Gynecology department with clinical picture suggestive of having EM or had previously diagnosed depending on radiologic workup were evaluated for the enrolment criteria.
Who may be able to join
- Women with clinical manifestations suggestive of having EM;
- Women who was professionally diagnosed;
- Women who was diagnosed by radiologic workup;
- Women were free of exclusion criteria.
Who cannot join
- Women with EM and were maintained on treatment or underwent operative interference during the last three months;
- Patients had autoimmune diseases, maintained on immunosuppressive therapy for any indication;
- Women with cancer elsewhere in the body or receiving adjuvant therapies for cancer;
- Patients receiving therapies for viral disorders especially COVID;
- Patients refusing to undergo the exploratory laparoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis: A Comparative Study Versus Exploratory Laparoscopy
Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers .
- Conditions
- Endometriosis
- Being tested
- Diagnostic laparoscopy, Full Blood Count (FBC)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic laparoscopyProcedure or surgery
All women will undergo exploratory laparoscopy under general anesthesia
Full Blood Count (FBC)Diagnostic test
Blood samples withdrawn from patients on EDITA tubes and gone through full blood count and differential leucocytic count
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described Receives: Procedure: Diagnostic laparoscopy; Diagnostic Test: Full Blood Count (FBC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indices' ability to predict EM stage
Number of patients was diagnosed with EM and got staged right through a calculated indices to the patients who went for exploratory laparoscopy which improve the chances of calculated indices facing the laparoscopy.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Jan 2023
- Primary completion30 Jul 2023
- Study completion25 Dec 2023
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 Benha UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sabra, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298617
- Sponsor's protocol ID
- RC 27.1.2024
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis: A Comparative Study Versus Exploratory Laparoscopy
- ClinicalTrials.gov ID
- NCT06298617
- Acronym / sponsor ID
- RC 27.1.2024
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 7 Mar 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.
Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Diagnostic laparoscopy, Diagnostic Test: Full Blood Count (FBC) |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women attending the outpatient of Gynecology department with clinical picture suggestive of having EM or had previously diagnosed depending on radiologic workup were evaluated for the enrolment criteria.
Key inclusion criteria (4 listed)
- Women with clinical manifestations suggestive of having EM;
- Women who was professionally diagnosed;
- Women who was diagnosed by radiologic workup;
- Women were free of exclusion criteria.
Key exclusion criteria (5 listed)
- Women with EM and were maintained on treatment or underwent operative interference during the last three months;
- Patients had autoimmune diseases, maintained on immunosuppressive therapy for any indication;
- Women with cancer elsewhere in the body or receiving adjuvant therapies for cancer;
- Patients receiving therapies for viral disorders especially COVID;
- Patients refusing to undergo the exploratory laparoscopy.
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 |
|---|---|---|
| Diagnostic laparoscopyAll women will undergo exploratory laparoscopy under general anesthesia | Procedure or surgery | Study group |
| Full Blood Count (FBC)Blood samples withdrawn from patients on EDITA tubes and gone through full blood count and differential leucocytic count | Diagnostic test | Study group |
Primary outcome
Indices' ability to predict EM stage
Time frame: 8 months
Number of patients was diagnosed with EM and got staged right through a calculated indices to the patients who went for exploratory laparoscopy which improve the chances of calculated indices facing the laparoscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Benha University at 1 site in Egypt.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Mar 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indices' ability to predict EM stage (time frame: 8 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 12 Mar 2024.