Raman Spectroscopy and Endometriosis

• Sponsor: Acibadem University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04015297
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis; Endometrioma	Diagnostic Test: raman analysis	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: The Role of Raman Spectroscopic Analysis for Endometriosis Diagnosis
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: control healthy controls	Diagnostic Test: raman analysis; negative or pozitive
Experimental: patient patients diagnosed with endometriosis	Diagnostic Test: raman analysis; negative or pozitive

Outcome Measures

Primary Outcome Measures

1. diagnostic specificity [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• proven endometriosis

Exclusion Criteria:

• having additional health conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bahar Yuksel	Istanbul		Turkey	34000

Sponsors and Collaborators

• Acibadem University

Investigators

• Study Director: Bahar Yuksel, md, esenler maternity and children's hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Eberhardt K, Stiebing C, Matthäus 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. Review.
• 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. Review.

• Responsible Party: Acibadem University
• ClinicalTrials.gov Identifier: NCT04015297
• Other Study ID Numbers: ob&gyn raman
• First Posted: Jul 10, 2019
• Last Update Posted: Jul 10, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Acibadem University: endometriosis; raman analaysis
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Jul 10, 2019