Relationship Between Pan Immune Inflammatory Index and Endometriosis and Endometriosis StagesNCT06142214
Relationship Between Pan Immune Inflammatory Index and Endometriosis
An observational study of Relationship Between Pan Immune Inflammatory Index and Endometriosis and Endometriosis Stages, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate whether there is a difference in terms of pan immune inflammatory index in patients with and without endometriosis and to investigate whether there is a correlation between the severity of endometriosis and this index in patients with endometriosis. 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
- Relationship Between Pan Immune Inflammatory Index and Endometriosis and Endometriosis Stages
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Aug 2023to 15 Feb 2024
- 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: Patients between the ages of 18-45, who applied to the Gynecology outpatient clinic of Etlik City Hospital and were followed up in our hospital, who were suspected for endometriosis on ultrasound or MRI or CT, and who were operated and whose postoperative pathology was compatible with endometrioma will be included in the study. When we look at the number of operations in our Gynecology Clinic, an average of 3 endometrioma operations are performed per week. Our study period is planned as 6 months and the number of patients is planned as 100. Patients who underwent bilateral tubal ligation in our Gynecology Clinic and who do not have any pelvic pathology will be included as the control group.
Who may be able to join
- Being between the ages of 18-45
- Patients with suspected endometrosis on ultrasonography or MRI or CT
- Patients with a postoperative pathologic diagnosis of endometrioma
- Patients without pelvic pathology operated for bilateral tubal ligation
Who cannot join
- Diagnosis or evidence of systemic inflammatory disease
- Having an adnexal mass other than endometriosis
- presence of infectious disease
- Mobite obesity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06000
About this study
Official title: Pan İmmun İnflamatuar İndeks (PIV) Ile Endometriosiz Arasındaki İlişki
The aim of this study was to investigate whether there is a difference in terms of pan immune inflammatory index in patients with and without endometriosis and to investigate whether there is a correlation between the severity of endometriosis and this index in patients with endometriosis. To reveal the importance of the pan immune inflammatory index in predicting the severity of the disease and to contribute to the literature by examining its relationship with a new index in this sense.
Read the detailed description
Endometrosis is a common estrogen-dependent chronic inflammatory disease that causes pelvic pain and infertility. Its etiology is complex and multifactorial and several theories have been proposed to explain its pathogenesis, which are not fully understood. Endometrial cells are characterized by extensive endometrial implants outside the uterus, especially in the ovaries, ligaments and peritoneal surfaces. These implants lead to inflammation resulting in scar tissue banding, also called endometrial adhesions in advanced stages (III and IV). Endometriosis affects 10-15% of reproductive women and is associated with different symptoms such as infertility, chronic pelvic pain, dyspareunia, dysmenorrhea and abnormal uterine bleeding. The American Society for Reproductive Medicine (ASRM) categorizes it into four stages according to the size of endometriotic implants in the ovaries, peritoneum and fallopian tubes and the severity of adhesion.
Stage I: This is also known as minimal endometriosis. In stage I, superficial implants and mild adhesions may grow outside the uterus. The score for minimal endometriosis is between one and five.
Stage II: This is also known as mild endometriosis. With stage II, implants may be superficial or deep with mild adhesions. In stage II, endometriosis may be widespread and deep implants may be present. Score six to 15 for mild endometriosis between Stage III: This is also known as moderate endometriosis. With stage III deep implants are available. Adhesions may also be thin and dense. As a result, endometriosis is more common than in Stage II. The score for moderate endometriosis is between 16 and 40.
Stage IV: This is also known as severe endometriosis. With stage IV, deep implants and dense adhesions are present. There may be superficial endometriosis and thin adhesions, but the disease is more widespread than in Stage III. Any score greater than 40 indicates severe endometriosis.
The pan-immune inflammatory index (neutrophil count X monocyte count X platelet count/lymphocyte count) is a scoring system of immune inflammatory cells in peripheral blood. Although this index was first studied in malignant diseases, it has been found to be associated with non-malignant diseases in subsequent studies.
In the light of the literature, we aimed to determine the relationship between pan immune inflammatory index and endometriosis and endometriosis stages.
- Conditions
- Relationship Between Pan Immune Inflammatory Index and Endometriosis and Endometriosis Stages
- Keywords
- endometriosis, endometriosis stages, pan immune inflammatory index
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis- Case group | Patients between the ages of 18-45, who applied to the Gynecology outpatient clinic of Etlik City Hospital and were followed up in our hospital, who were suspected of endometriosis on ultrasound or MRI or CT, and who were operated and whose postoperative pathology was compatible with endometriosis will be included in the study. | |
| Healthy patients-Control | Patients who underwent bilateral tubal ligation in our Gynecology Clinic and who did not have any pelvic pathology will be included as the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of endometriosis -Pan Immune Inflammatory Index
neutrophil count x monocyte count x platelet count/lymphocyte count
Measured: Pre-operative
Secondary outcomes (1)
Stage of endometriosis -Pan Immune Inflammatory Index
neutrophil count x monocyte count x platelet count/lymphocyte count
Measured: Pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start9 Aug 2023
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship Between Pan Immune Inflammatory Index and Endometriosis and Endometriosis StagesStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dilara SARIKAYA KURT, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142214
- Sponsor's protocol ID
- AESH-EK1-2023-449
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient data is not open to access due to hospital policy. however, the principal investigator can be reached via e-mail if necessary
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan İmmun İnflamatuar İndeks (PIV) Ile Endometriosiz Arasındaki İlişki
- ClinicalTrials.gov ID
- NCT06142214
- Acronym / sponsor ID
- AESH-EK1-2023-449
- Conditions
- Relationship Between Pan Immune Inflammatory Index and Endometriosis and Endometriosis Stages
- Keywords
- endometriosis, endometriosis stages, pan immune inflammatory index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 21 Nov 2023 (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.
The aim of this study was to investigate whether there is a difference in terms of pan immune inflammatory index in patients with and without endometriosis and to investigate whether there is a correlation between the severity of endometriosis and this index in patients with endometriosis. To reveal the importance of the pan immune inflammatory index in predicting the severity of the disease and to contribute to the literature by examining its relationship with a new index in this sense.
Detailed description
Endometrosis is a common estrogen-dependent chronic inflammatory disease that causes pelvic pain and infertility. Its etiology is complex and multifactorial and several theories have been proposed to explain its pathogenesis, which are not fully understood. Endometrial cells are characterized by extensive endometrial implants outside the uterus, especially in the ovaries, ligaments and peritoneal surfaces. These implants lead to inflammation resulting in scar tissue banding, also called endometrial adhesions in advanced stages (III and IV). Endometriosis affects 10-15% of reproductive women and is associated with different symptoms such as infertility, chronic pelvic pain, dyspareunia, dysmenorrhea and abnormal uterine bleeding. The American Society for Reproductive Medicine (ASRM) categorizes it into four stages according to the size of endometriotic implants in the ovaries, peritoneum and fallopian tubes and the severity of adhesion.
Stage I: This is also known as minimal endometriosis. In stage I, superficial implants and mild adhesions may grow outside the uterus. The score for minimal endometriosis is between one and five.
Stage II: This is also known as mild endometriosis. With stage II, implants may be superficial or deep with mild adhesions. In stage II, endometriosis may be widespread and deep implants may be present. Score six to 15 for mild endometriosis between Stage III: This is also known as moderate endometriosis. With stage III deep implants are available. Adhesions may also be thin and dense. As a result, endometriosis is more common than in Stage II. The score for moderate endometriosis is between 16 and 40.
Stage IV: This is also known as severe endometriosis. With stage IV, deep implants and dense adhesions are present. There may be superficial endometriosis and thin adhesions, but the disease is more widespread than in Stage III. Any score greater than 40 indicates severe endometriosis.
The pan-immune inflammatory index (neutrophil count X monocyte count X platelet count/lymphocyte count) is a scoring system of immune inflammatory cells in peripheral blood. Although this index was first studied in malignant diseases, it has been found to be associated with non-malignant diseases in subsequent studies.
In the light of the literature, we aimed to determine the relationship between pan immune inflammatory index and endometriosis and endometriosis stages.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis- Case group | – | –Patients between the ages of 18-45, who applied to the Gynecology outpatient clinic of Etlik City Hospital and were followed up in our hospital, who were suspected of endometriosis on ultrasound or MRI or CT, and who were operated and whose postoperative pathology was compatible with endometriosis will be included in the study. |
| Healthy patients-Control | – | –Patients who underwent bilateral tubal ligation in our Gynecology Clinic and who did not have any pelvic pathology will be included as the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients between the ages of 18-45, who applied to the Gynecology outpatient clinic of Etlik City Hospital and were followed up in our hospital, who were suspected for endometriosis on ultrasound or MRI or CT, and who were operated and whose postoperative pathology was compatible with endometrioma will be included in the study. When we look at the number of operations in our Gynecology Clinic, an average of 3 endometrioma operations are performed per week. Our study period is planned as 6 months and the number of patients is planned as 100. Patients who underwent bilateral tubal ligation in our Gynecology Clinic and who do not have any pelvic pathology will be included as the control group.
Key inclusion criteria (4 listed)
- Being between the ages of 18-45
- Patients with suspected endometrosis on ultrasonography or MRI or CT
- Patients with a postoperative pathologic diagnosis of endometrioma
- Patients without pelvic pathology operated for bilateral tubal ligation
Key exclusion criteria (4 listed)
- Diagnosis or evidence of systemic inflammatory disease
- Having an adnexal mass other than endometriosis
- presence of infectious disease
- Mobite obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of endometriosis -Pan Immune Inflammatory Index
Time frame: Pre-operative
neutrophil count x monocyte count x platelet count/lymphocyte count
1 secondary outcome
Stage of endometriosis -Pan Immune Inflammatory Index
Time frame: Pre-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No. patient data is not open to access due to hospital policy. however, the principal investigator can be reached via e-mail if necessary
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 Relationship Between Pan Immune Inflammatory Index and Endometriosis and Endometriosis Stages, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 4 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 21 Nov 2023. 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 Turkey (Türkiye). 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?
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?
Diagnosis of endometriosis -Pan Immune Inflammatory Index (time frame: Pre-operative). 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 21 Nov 2023.