Relationship Between Endoplasmic Reticulum Stress and Pai... | NCT04440397

Studies
Relationship Between Endoplasmic Reticulum Stress and Pain in Patients With Endometriosis

NCT04440397

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Aug 7, 2020Actual

Enrollment

86Actual

Phase

Not provided

Conditions

Endometriosis
Endoplasmic Reticulum Stress
Endometriosis-related Pain

Interventions

xbp-1 - endometriosis patients group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2020Actual

Primary Completion Date

Aug 1, 2020Actual

Completion Date

Aug 4, 2020Actual

First Submitted Date

Jun 17, 2020

First Submission Date that Met QC Criteria

Jun 17, 2020

First Posted Date

Jun 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2020

Last Update Posted Date

Aug 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pınar Yalcin bahat, Principal Investigator, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients. XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain pathogenesis.

Detailed Description

Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and ultrasound, without known rheumatological or metabolic diseases were included in the study. Most of the patients are composed of newly diagnosed patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
xbp-1 - endometriosis patients group	Other	Patients diagnosed with endometriosis by surgery and ultrasound and whose xbp-1 level was examined

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis.		5 months

Secondary Outcomes

Measure	Description	Time Frame
serum XBP-1levels in patients wit endometriosis		5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed endometriosis with ultrasound or surgery
no metabolic diseases
no rheumatological diseases

Exclusion Criteria:

Immune modulator, hormonal, anti-inflammatory use history in the last 3 months

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Women between the ages of 18-50 who were diagnosed with endometriosis by ultrasound or surgery and who did not have any rheumatological and metaboli disease were included in the study. women with drug use indicated in the last 3 months were excluded from the study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pinar Yalcin Bahat		Istanbul	İ̇stanbul	34000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided