Back to resultsRaman Spectroscopy and Endometriosis
Primary Purpose
Endometriosis, Endometrioma
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
raman analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometriosis focused on measuring endometriosis, raman analaysis
Eligibility Criteria
Inclusion Criteria:
- proven endometriosis
Exclusion Criteria:
- having additional health conditions
Sites / Locations
- Bahar YukselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
control
patient
Arm Description
healthy controls
patients diagnosed with endometriosis
Outcomes
Primary Outcome Measures
diagnostic specificity
differentiating endometriosis patients from healthy controls by computer based technology designed with raman data
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04015297
Brief Title
Raman Spectroscopy and Endometriosis
Official Title
The Role of Raman Spectroscopic Analysis for Endometriosis Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acibadem University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.
Detailed Description
Endometriosis is a chronic disease whose molecular basis is still unknown and diagnostic methods are controversial. The diagnosis is still invasive and there are no accepted ways which are molecular-based and noninvasive. Raman spectroscopy is a vibrational spectroscopy technique which can analyze specific spectral patterns, substances and molecular changes with high specificity. We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Endometrioma
Keywords
endometriosis, raman analaysis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Experimental
Arm Description
healthy controls
Arm Title
patient
Arm Type
Experimental
Arm Description
patients diagnosed with endometriosis
Intervention Type
Diagnostic Test
Intervention Name(s)
raman analysis
Intervention Description
negative or pozitive
Primary Outcome Measure Information:
Title
diagnostic specificity
Description
differentiating endometriosis patients from healthy controls by computer based technology designed with raman data
Time Frame
2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females have endometriosis
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
proven endometriosis
Exclusion Criteria:
having additional health conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahar Yuksel
Phone
05424732003
Email
baharyl86@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahar Yuksel, md
Organizational Affiliation
esenler maternity and children's hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bahar Yuksel
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahar Yuksel
Phone
5424732003
Email
baharyl86@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
only by request
Citations:
PubMed Identifier
26277185
Citation
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.
Results Reference
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PubMed Identifier
25872466
Citation
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.
Results Reference
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Learn more about this trial
Raman Spectroscopy and Endometriosis
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