NCT04015297

Brief Summary

We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

July 6, 2019

Last Update Submit

July 6, 2019

Conditions

EndometriosisEndometrioma

Keywords

endometriosisraman analaysis

Outcome Measures

Primary Outcomes (1)

  • diagnostic specificity

    differentiating endometriosis patients from healthy controls by computer based technology designed with raman data

    2 years

Study Arms (2)

control

EXPERIMENTAL

healthy controls

Diagnostic Test: raman analysis

patient

EXPERIMENTAL

patients diagnosed with endometriosis

Diagnostic Test: raman analysis

Interventions

raman analysisDIAGNOSTIC_TEST

negative or pozitive

controlpatient

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales have endometriosis
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • proven endometriosis

You may not qualify if:

  • having additional health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahar Yuksel

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Lyng FM, Traynor D, Ramos IR, Bonnier F, Byrne HJ. Raman spectroscopy for screening and diagnosis of cervical cancer. Anal Bioanal Chem. 2015 Nov;407(27):8279-89. doi: 10.1007/s00216-015-8946-1. Epub 2015 Aug 16.

    PMID: 26277185BACKGROUND

  • Eberhardt K, Stiebing C, Matthaus C, Schmitt M, Popp J. Advantages and limitations of Raman spectroscopy for molecular diagnostics: an update. Expert Rev Mol Diagn. 2015 Jun;15(6):773-87. doi: 10.1586/14737159.2015.1036744. Epub 2015 Apr 15.

    PMID: 25872466BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bahar Yuksel, md

    esenler maternity and children's hospital

    STUDY DIRECTOR

Central Study Contacts

Bahar Yuksel

CONTACT

05424732003baharyl86@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2019

First Posted

July 10, 2019

Study Start

January 1, 2019

Primary Completion

December 1, 2019

Study Completion

September 1, 2020

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

TU(1)