Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05060120
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2021-09-12
Brief Title:
Biomarker Panel in Ovarian Torsion
Sponsor:
Assuta Ashdod Hospital
Organization:
Assuta Ashdod Hospital
Study Overview
Official Title:
Biomarker Panel for Early Diagnosis of Ovarian Torsion
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion
Detailed Description:
The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion
The specifc aims of the current study are
1 Screen for changes in blood protein biomarkers concentrations specifc for patients with ovarian torsion The biomarkers are D-Dimer 217-5280 ngml FABP4A-FABP 0637-155 ngml GM-CSF 0012-298 ngml ICAM-1CD54 69-1674 ngml IFN-γ 0058-142 ngml IL-1α 0005-127 ngml IL-6 0005-12 ngml IL-10 0005-12 ngml IL-17IL-17A 0012-31 ngml Park7DJ-1 026- 631 ngml TNF-α 001-24 ngml TSLP 0003-07 ngml VCAM-1CD106 78-1891 ngml and VEGF 0008-24 ngml
2 Compare the amount of oxidative stress defense proteins SOD1 Catalase and Thioredoxin amount in the peritoneal fluid wash between patients with or without confirmed ovarian torsion To our knowledge this is the first study that specifically evaluates the expression of oxidation stress defense proteins in ovarian torsion The results will enable us to decide whether to include oxidation stress biomarkers within the panel
3 Study population methodology and techniques
A prospective 12-24 months study
20 Patients with confirmed ovarian torsion will be enrolled
The patients will complete a questionnaire prior to and following the procedure
35ml blood samples will be obtained immediately before laparoscopy postoperative day and four weeks after laparoscopy during the follow-up
The peritoneal fluid wash will be collected during the laparoscopy from 14 patients out of the 20 enrolled that will provide additional written consent specific for the procedure
20 Patients suspected of ovarian torsion with no ovarian torsion as confirmed by laparoscopy will be enrolled
The patients will complete a questionnaire prior to and following the procedure
5ml blood samples will be obtained immediately before laparoscopy and four weeks after laparoscopy during the follow-up
The peritoneal fluid wash will be collected during the laparoscopy from 14 patients out of the 20 enrolled that will provide additional written consent specific for the procedure
20 Healthy controls will be enrolled and provide a 5ml blood sample
The specifc aims of the current study are
1 Screen for changes in blood protein biomarkers concentrations specifc for patients with ovarian torsion The biomarkers are D-Dimer 217-5280 ngml FABP4A-FABP 0637-155 ngml GM-CSF 0012-298 ngml ICAM-1CD54 69-1674 ngml IFN-γ 0058-142 ngml IL-1α 0005-127 ngml IL-6 0005-12 ngml IL-10 0005-12 ngml IL-17IL-17A 0012-31 ngml Park7DJ-1 026- 631 ngml TNF-α 001-24 ngml TSLP 0003-07 ngml VCAM-1CD106 78-1891 ngml and VEGF 0008-24 ngml
2 Compare the amount of oxidative stress defense proteins SOD1 Catalase and Thioredoxin amount in the peritoneal fluid wash between patients with or without confirmed ovarian torsion To our knowledge this is the first study that specifically evaluates the expression of oxidation stress defense proteins in ovarian torsion The results will enable us to decide whether to include oxidation stress biomarkers within the panel
3 Study population methodology and techniques
A prospective 12-24 months study
20 Patients with confirmed ovarian torsion will be enrolled
The patients will complete a questionnaire prior to and following the procedure
35ml blood samples will be obtained immediately before laparoscopy postoperative day and four weeks after laparoscopy during the follow-up
The peritoneal fluid wash will be collected during the laparoscopy from 14 patients out of the 20 enrolled that will provide additional written consent specific for the procedure
20 Patients suspected of ovarian torsion with no ovarian torsion as confirmed by laparoscopy will be enrolled
The patients will complete a questionnaire prior to and following the procedure
5ml blood samples will be obtained immediately before laparoscopy and four weeks after laparoscopy during the follow-up
The peritoneal fluid wash will be collected during the laparoscopy from 14 patients out of the 20 enrolled that will provide additional written consent specific for the procedure
20 Healthy controls will be enrolled and provide a 5ml blood sample
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None