EndometriosisNCT04015297
Raman Spectroscopy and Endometriosis
A study testing raman analysis in people with Endometriosis and Endometrioma, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Endometrioma
- What is being tested?
- raman analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- proven endometriosis
Who cannot join
- having additional health conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bahar Yuksel
Istanbul, 34000
Bahar Yuksel, 5424732003, baharyl86@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis, Endometrioma
- Being tested
- raman analysis
- Keywords
- endometriosis, raman analaysis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raman analysisDiagnostic test
negative or pozitive
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | healthy controls Receives: Diagnostic Test: raman analysis |
| patient | Experimental | patients diagnosed with endometriosis Receives: Diagnostic Test: raman analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic specificity
differentiating endometriosis patients from healthy controls by computer based technology designed with raman data
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jan 2019
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bahar Yuksel, md, Study director, esenler maternity and children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015297
- Sponsor's protocol ID
- ob&gyn raman
- Status last verified
- Jul 2019
- First submitted
- 6 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only by request
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.
PubMed 26277185Eberhardt 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.
PubMed 25872466
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Raman Spectroscopic Analysis for Endometriosis Diagnosis
- ClinicalTrials.gov ID
- NCT04015297
- Acronym / sponsor ID
- ob&gyn raman
- Conditions
- Endometriosis, Endometrioma
- Keywords
- endometriosis, raman analaysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Diagnostic Test: raman analysishealthy controls |
| patient | Experimental | Diagnostic Test: raman analysispatients diagnosed with endometriosis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- proven endometriosis
Key exclusion criteria (1 listed)
- having additional health conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| raman analysisnegative or pozitive | Diagnostic test | control, patient |
Primary outcome
diagnostic specificity
Time frame: 2 years
differentiating endometriosis patients from healthy controls by computer based technology designed with raman data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Background: PubMed 26277185Lyng 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.
- Background: PubMed 25872466Eberhardt 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.
- Individual participant dataSharing planned: Undecided. only by request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahar Yuksel, md study director
esenler maternity and children's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing raman analysis in people with Endometriosis and Endometrioma, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahar Yuksel (05424732003, baharyl86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic specificity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04015297, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.