Endometrium CancerNCT06192017
Development of a Molecular Diagnostic Tool for Endometrial Cancer.
An observational study of Endometrium Cancer, run by MiMARK Diagnostics, S.L. at 26 sites in Spain.
Trial summary
WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrium Cancer
- What is being tested?
- WomEC
- How many people
- 1,950 participants
- Where
- 26 sitesSpain
- Study dates
- 18 Oct 2023to 31 Jul 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- Women only
- Adult, Older adult
Study population: Post-menopausal women presenting AUB entering to the EC diagnostic process at the clinical consultancy or emergency room.
Who may be able to join
- Post-menopausal women (≥1 year without menstruation) with AUB who present with:
- Endometrium > 3mm by transvaginal ultrasound, OR
- Endometrium ≤ 3mm who meet at least one of the following criteria:
- Persistent symptoms (more than one episode of metrorrhagia) ii. Heterogenous endometrium on transvaginal ultrasonography iii. Risk factors (BMI ≥ 30, use of tamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation.
- Obtaining written informed consent
Who cannot join
- Women with an active pelvic infection.
- Women who have had viral infections with evidence of active and latent disease such as Hepatitis B, Hepatitis C, and HIV infection. Patients who have had Hepatitis C in the past but who have been successfully treated and in whom viral replication has not been observed in the last year will be included.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Spain26 sites
Hospital Clínico de Santiago
A Coruña, Galicia, 15706
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Dexeus - Quirón de Barcelona
Barcelona, Barcelona, 08028
Hospital Universitari Campus Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clinic
Barcelona, Barcelona, 08036
Hospital Universitario de Puerto Real
Cadiz, 11510
Hospital General Universitari de Castelló
Castellon, 12004
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Hospital Virgen de las Nieves
Granada, Granada, 18014
Hospital Universitario de Igualada
Igualada, Barcelona, 08700
Hospital Universitari de Bellvitge - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
Hospital Universitario de León
León, 24008
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Universitario Quirónsalud Madrid
Madrid, Madrid, 28223
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03186
Hospital General Universitari de València
Valencia, Valencia, 46014
Hospital Universitario y Politécnico de La Fe
Valencia, Valencia, 46026
Hospital Universitario de la Plana
Villarreal, Castellon, 12540
Hospital Miguel Servet
Zaragoza, 50009
About this study
WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. The aim of the study consists in validating WomEC's ELISA test, creating and freezing an algorithm to rule out EC in post-menopausal women with abnormal uterine bleeding (AUB).
- Conditions
- Endometrium Cancer
- Being tested
- WomEC
- Keywords
- Endometrial Cancer, EC
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WomECDiagnostic test
The study will collect pipelle biopsies from post-menopausal women presenting with AUB entering to the EC diagnostic process at the clinical consultancy or emergency room. In the study an endometrial biopsy by aspiration will be collected (i.e., pipelle biopsy) and it will be used for (1) diagnostic purposes following current procedures (i.e., pathological examination and diagnosis); (2) placed in a collection tube for WomEC test.
| Study group | Role | What they receive |
|---|---|---|
| Post-menopausal women with AUB | The patients will be divided into different study groups: "Control" and cases or "EC", the latter could be subdivided and analyzed in separate groups related to their prognosis. The "Control" patients are those patients with symptoms compatible with endometrial cancer but who are diagnosed with benign and / or healthy pathology; while "EC" patients present associated symptoms and are diagnosed with endometrial cancer. Receives: Diagnostic Test: WomEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regulatory Requirements Study
Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed WomEC's ELISA test.
Measured: 12 months
Algorithm training with Proprietary Antibodies
Train the current WomEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination to rule out EC in post- menopausal women with AUB using MiMARK's proprietary antibodies.
Measured: 12 months
Algorithm testing and freeze
To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB.
Measured: 12 months
Secondary outcomes (4)
To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy.
Test the ability of WomEC to discriminate between EC and non-EC patients.
Measured: 12 months
Evaluation of the performance of different models of WomEC to determine histological subtype.
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine an histological subtype.
Measured: 12 months
Evaluation of the performance of WomEC to determine other prognostic factors of EC.
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine other prognostic factors of EC.
Measured: 12 months
Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia.
Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to diagnose endometrial atypical hyperplasia.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start18 Oct 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Endometrium CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,950 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- MiMARK Diagnostics, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Vall d'Hebron
- Responsible party
- Sponsor
- Investigators
- Antonio Gil-Moreno, MD, PhD, Principal investigator, Hospital Universitari Campus Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192017
- Sponsor's protocol ID
- WomEC SEGO
- Status last verified
- Aug 2025
- First submitted
- 20 Dec 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
PubMed 35020204Dueholm M, Hjorth IMD, Dahl K, Hansen ES, Ortoft G. Ultrasound Scoring of Endometrial Pattern for Fast-track Identification or Exclusion of Endometrial Cancer in Women with Postmenopausal Bleeding. J Minim Invasive Gynecol. 2019 Mar-Apr;26(3):516-525. doi: 10.1016/j.jmig.2018.06.010. Epub 2018 Jun 23.
PubMed 29944932Clarke MA, Long BJ, Del Mar Morillo A, Arbyn M, Bakkum-Gamez JN, Wentzensen N. Association of Endometrial Cancer Risk With Postmenopausal Bleeding in Women: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Sep 1;178(9):1210-1222. doi: 10.1001/jamainternmed.2018.2820.
PubMed 30083701van Hanegem N, Prins MM, Bongers MY, Opmeer BC, Sahota DS, Mol BW, Timmermans A. The accuracy of endometrial sampling in women with postmenopausal bleeding: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2016 Feb;197:147-55. doi: 10.1016/j.ejogrb.2015.12.008. Epub 2015 Dec 19.
PubMed 26748390Bradley LD. Complications in hysteroscopy: prevention, treatment and legal risk. Curr Opin Obstet Gynecol. 2002 Aug;14(4):409-15. doi: 10.1097/00001703-200208000-00008.
PubMed 12151831Helpman L, Kupets R, Covens A, Saad RS, Khalifa MA, Ismiil N, Ghorab Z, Dube V, Nofech-Mozes S. Assessment of endometrial sampling as a predictor of final surgical pathology in endometrial cancer. Br J Cancer. 2014 Feb 4;110(3):609-15. doi: 10.1038/bjc.2013.766. Epub 2013 Dec 24.
PubMed 24366295Visser NCM, Reijnen C, Massuger LFAG, Nagtegaal ID, Bulten J, Pijnenborg JMA. Accuracy of Endometrial Sampling in Endometrial Carcinoma: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Oct;130(4):803-813. doi: 10.1097/AOG.0000000000002261.
PubMed 28885397Colas E, Perez C, Cabrera S, Pedrola N, Monge M, Castellvi J, Eyzaguirre F, Gregorio J, Ruiz A, Llaurado M, Rigau M, Garcia M, Ertekin T, Montes M, Lopez-Lopez R, Carreras R, Xercavins J, Ortega A, Maes T, Rosell E, Doll A, Abal M, Reventos J, Gil-Moreno A. Molecular markers of endometrial carcinoma detected in uterine aspirates. Int J Cancer. 2011 Nov 15;129(10):2435-44. doi: 10.1002/ijc.25901. Epub 2011 Apr 8.
PubMed 21207424Perez-Sanchez C, Colas E, Cabrera S, Falcon O, Sanchez-del-Rio A, Garcia E, Fernandez-de-Castillo L, Muruzabal JC, Alvarez E, Fiol G, Gonzalez C, Torrejon R, Moral E, Campos M, Repolles M, Carreras R, Jimenez-Lopez J, Xercavins J, Aibar E, Perdones-Montero A, Lalanne E, Palicio M, Maes T, Rosell-Vives E, Nieto C, Ortega A, Pedrola N, Llaurado M, Rigau M, Doll A, Abal M, Ponce J, Gil-Moreno A, Reventos J. Molecular diagnosis of endometrial cancer from uterine aspirates. Int J Cancer. 2013 Nov 15;133(10):2383-91. doi: 10.1002/ijc.28243. Epub 2013 Jun 21.
PubMed 23649867Martinez-Garcia E, Lopez-Gil C, Campoy I, Vallve J, Coll E, Cabrera S, Ramon Y Cajal S, Matias-Guiu X, Van Oostrum J, Reventos J, Gil-Moreno A, Colas E. Advances in endometrial cancer protein biomarkers for use in the clinic. Expert Rev Proteomics. 2018 Jan;15(1):81-99. doi: 10.1080/14789450.2018.1410061. Epub 2017 Nov 30.
PubMed 29183259Martinez-Garcia E, Lesur A, Devis L, Campos A, Cabrera S, van Oostrum J, Matias-Guiu X, Gil-Moreno A, Reventos J, Colas E, Domon B. Development of a sequential workflow based on LC-PRM for the verification of endometrial cancer protein biomarkers in uterine aspirate samples. Oncotarget. 2016 Aug 16;7(33):53102-53115. doi: 10.18632/oncotarget.10632.
PubMed 27447978Martinez-Garcia E, Lesur A, Devis L, Cabrera S, Matias-Guiu X, Hirschfeld M, Asberger J, van Oostrum J, Casares de Cal MLA, Gomez-Tato A, Reventos J, Domon B, Colas E, Gil-Moreno A. Targeted Proteomics Identifies Proteomic Signatures in Liquid Biopsies of the Endometrium to Diagnose Endometrial Cancer and Assist in the Prediction of the Optimal Surgical Treatment. Clin Cancer Res. 2017 Nov 1;23(21):6458-6467. doi: 10.1158/1078-0432.CCR-17-0474. Epub 2017 Aug 8.
PubMed 28790116DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
PubMed 3203132Fawcett T. An introduction to ROC analysis. Pattern Recognit Lett. North-Holland; 2006;27:861-74.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Molecular Diagnostic Tool for Endometrial Cancer.
- ClinicalTrials.gov ID
- NCT06192017
- Acronym / sponsor ID
- WomEC SEGO
- Conditions
- Endometrium Cancer
- Keywords
- Endometrial Cancer, EC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,950 participants (actual)
- Lead sponsor
- MiMARK Diagnostics, S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Vall d'Hebron
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 5 Jan 2024 (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.
WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. The aim of the study consists in validating WomEC's ELISA test, creating and freezing an algorithm to rule out EC in post-menopausal women with abnormal uterine bleeding (AUB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-menopausal women with AUB | – | Diagnostic Test: WomECThe patients will be divided into different study groups: "Control" and cases or "EC", the latter could be subdivided and analyzed in separate groups related to their prognosis. The "Control" patients are those patients with symptoms compatible with endometrial cancer but who are diagnosed with benign and / or healthy pathology; while "EC" patients present associated symptoms and are diagnosed with endometrial cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Post-menopausal women presenting AUB entering to the EC diagnostic process at the clinical consultancy or emergency room.
Key inclusion criteria (5 listed)
- Post-menopausal women (≥1 year without menstruation) with AUB who present with:
- Obtaining written informed consent
Key exclusion criteria (2 listed)
- Women with an active pelvic infection.
- Women who have had viral infections with evidence of active and latent disease such as Hepatitis B, Hepatitis C, and HIV infection. Patients who have had Hepatitis C in the past but who have been successfully treated and in whom viral replication has not been observed in the last year will be included.
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 |
|---|---|---|
| WomECThe study will collect pipelle biopsies from post-menopausal women presenting with AUB entering to the EC diagnostic process at the clinical consultancy or emergency room. In the study an endometrial biopsy by aspiration will be collected (i.e., pipelle biopsy) and it will be used for (1) diagnostic purposes following current procedures (i.e., pathological examination and diagnosis); (2) placed in a collection tube for WomEC test. | Diagnostic test | Post-menopausal women with AUB |
Primary outcome
Regulatory Requirements Study
Time frame: 12 months
Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed WomEC's ELISA test.
Algorithm training with Proprietary Antibodies
Time frame: 12 months
Train the current WomEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination to rule out EC in post- menopausal women with AUB using MiMARK's proprietary antibodies.
Algorithm testing and freeze
Time frame: 12 months
To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB.
4 secondary outcomes
To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy.
Time frame: 12 months
Evaluation of the performance of different models of WomEC to determine histological subtype.
Time frame: 12 months
Evaluation of the performance of WomEC to determine other prognostic factors of EC.
Time frame: 12 months
Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 35020204Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
- Background: PubMed 29944932Dueholm M, Hjorth IMD, Dahl K, Hansen ES, Ortoft G. Ultrasound Scoring of Endometrial Pattern for Fast-track Identification or Exclusion of Endometrial Cancer in Women with Postmenopausal Bleeding. J Minim Invasive Gynecol. 2019 Mar-Apr;26(3):516-525. doi: 10.1016/j.jmig.2018.06.010. Epub 2018 Jun 23.
- Background: PubMed 30083701Clarke MA, Long BJ, Del Mar Morillo A, Arbyn M, Bakkum-Gamez JN, Wentzensen N. Association of Endometrial Cancer Risk With Postmenopausal Bleeding in Women: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Sep 1;178(9):1210-1222. doi: 10.1001/jamainternmed.2018.2820.
- Background: PubMed 26748390van Hanegem N, Prins MM, Bongers MY, Opmeer BC, Sahota DS, Mol BW, Timmermans A. The accuracy of endometrial sampling in women with postmenopausal bleeding: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2016 Feb;197:147-55. doi: 10.1016/j.ejogrb.2015.12.008. Epub 2015 Dec 19.
- Background: PubMed 12151831Bradley LD. Complications in hysteroscopy: prevention, treatment and legal risk. Curr Opin Obstet Gynecol. 2002 Aug;14(4):409-15. doi: 10.1097/00001703-200208000-00008.
- Background: PubMed 24366295Helpman L, Kupets R, Covens A, Saad RS, Khalifa MA, Ismiil N, Ghorab Z, Dube V, Nofech-Mozes S. Assessment of endometrial sampling as a predictor of final surgical pathology in endometrial cancer. Br J Cancer. 2014 Feb 4;110(3):609-15. doi: 10.1038/bjc.2013.766. Epub 2013 Dec 24.
- Background: PubMed 28885397Visser NCM, Reijnen C, Massuger LFAG, Nagtegaal ID, Bulten J, Pijnenborg JMA. Accuracy of Endometrial Sampling in Endometrial Carcinoma: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Oct;130(4):803-813. doi: 10.1097/AOG.0000000000002261.
- Background: PubMed 21207424Colas E, Perez C, Cabrera S, Pedrola N, Monge M, Castellvi J, Eyzaguirre F, Gregorio J, Ruiz A, Llaurado M, Rigau M, Garcia M, Ertekin T, Montes M, Lopez-Lopez R, Carreras R, Xercavins J, Ortega A, Maes T, Rosell E, Doll A, Abal M, Reventos J, Gil-Moreno A. Molecular markers of endometrial carcinoma detected in uterine aspirates. Int J Cancer. 2011 Nov 15;129(10):2435-44. doi: 10.1002/ijc.25901. Epub 2011 Apr 8.
- Background: PubMed 23649867Perez-Sanchez C, Colas E, Cabrera S, Falcon O, Sanchez-del-Rio A, Garcia E, Fernandez-de-Castillo L, Muruzabal JC, Alvarez E, Fiol G, Gonzalez C, Torrejon R, Moral E, Campos M, Repolles M, Carreras R, Jimenez-Lopez J, Xercavins J, Aibar E, Perdones-Montero A, Lalanne E, Palicio M, Maes T, Rosell-Vives E, Nieto C, Ortega A, Pedrola N, Llaurado M, Rigau M, Doll A, Abal M, Ponce J, Gil-Moreno A, Reventos J. Molecular diagnosis of endometrial cancer from uterine aspirates. Int J Cancer. 2013 Nov 15;133(10):2383-91. doi: 10.1002/ijc.28243. Epub 2013 Jun 21.
- Background: PubMed 29183259Martinez-Garcia E, Lopez-Gil C, Campoy I, Vallve J, Coll E, Cabrera S, Ramon Y Cajal S, Matias-Guiu X, Van Oostrum J, Reventos J, Gil-Moreno A, Colas E. Advances in endometrial cancer protein biomarkers for use in the clinic. Expert Rev Proteomics. 2018 Jan;15(1):81-99. doi: 10.1080/14789450.2018.1410061. Epub 2017 Nov 30.
- Background: PubMed 27447978Martinez-Garcia E, Lesur A, Devis L, Campos A, Cabrera S, van Oostrum J, Matias-Guiu X, Gil-Moreno A, Reventos J, Colas E, Domon B. Development of a sequential workflow based on LC-PRM for the verification of endometrial cancer protein biomarkers in uterine aspirate samples. Oncotarget. 2016 Aug 16;7(33):53102-53115. doi: 10.18632/oncotarget.10632.
- Individual participant dataSharing planned: No
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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.
Antonio Gil-Moreno, MD, PhD principal investigator
Hospital Universitari Campus Vall d'Hebron
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrium Cancer, run by MiMARK Diagnostics, S.L. at 26 sites in Spain.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regulatory Requirements Study (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT06192017, which also lists 17 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 28 Aug 2025.