Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214260
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-10
Brief Title:
Menstrual Blood Proteomic Profile in Women With Endometriosis PROTEO-ENDO Study
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Proteomic Profile in Women With Endometriosis PROTEO-ENDO Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
PROTEO-ENDO
Brief 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 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 serumblood 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 2023126
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