- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015297
Raman Spectroscopy and Endometriosis
July 6, 2019 updated by: Acibadem University
The Role of Raman Spectroscopic Analysis for Endometriosis Diagnosis
We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bahar Yuksel
- Phone Number: 05424732003
- Email: baharyl86@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34000
- Recruiting
- Bahar Yuksel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- proven endometriosis
Exclusion Criteria:
- having additional health conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: control
healthy controls
|
negative or pozitive
|
EXPERIMENTAL: patient
patients diagnosed with endometriosis
|
negative or pozitive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diagnostic specificity
Time Frame: 2 years
|
differentiating endometriosis patients from healthy controls by computer based technology designed with raman data
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bahar Yuksel, md, esenler maternity and children's hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2019
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
September 1, 2020
Study Registration Dates
First Submitted
July 6, 2019
First Submitted That Met QC Criteria
July 6, 2019
First Posted (ACTUAL)
July 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 10, 2019
Last Update Submitted That Met QC Criteria
July 6, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ob&gyn raman
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
only by request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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