Leiomyoma, UterineMYOSARCIINCT04935333
Accuracy of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
An observational study of Leiomyoma, Uterine and Leiomyosarcoma Uterus, run by Igenomix at 21 sites in Spain.
Trial summary
The development of precise and non-invasive diagnostic methods is a priority in areas such as gynaecology and oncology, and above all in improving the health of those patients with a surgical indication for hysterectomy, laparoscopic or laparotomic myomectomy for diagnosis of uterine tumours. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma, Uterine, Leiomyosarcoma Uterus
- What is being tested?
- Collection of Leiomyoma samples and Collection of Leiomyosarcoma samples
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 21 sitesSpain
- Study dates
- Sep 2021to May 2023
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women between 18 and 80 years old and with a body mass index (BMI) of 18.5-40.0 kg / m2, with suspected myometrial tumour (leiomyoma / leiomyosarcoma) based on clinical symptoms and imaging diagnosis, will be evaluated in their referral centre, verifying that they meet the inclusion / exclusion criteria to participate in the study. Women with the same age and BMI but without a uterine tumour will be used as control patients.
Who may be able to join
- Patients who voluntarily sign the informed consent approved by the Research Ethics Committee (CEI) after having been duly informed of the nature of the study, before carrying out any test related to it, knowing the potential risks, benefits and discomforts derived from their participation. Participants should be informed that they may leave the study at any time, without this entailing any consequence for their subsequent medical care.
- BMI = 18.5-40 kg / m2
- Age = 18-80 years
- Surgical indication according to usual clinical practice, due to suspicion of a tumour mass in the uterus, either primary (stages I-IV) or recurrence, but without prior chemotherapy or radiotherapy (at the time of primary diagnosis or prior to recurrence) .
- Note: Control patients will have the same inclusion criteria for BMI and age but without uterine tumour pathology.
Who cannot join
- Patients who have participated in a clinical trial during the last 30 days unless it is approved by the sponsor as it does not interfere with the current study.
- Patients who have received chemotherapy or radiotherapy before taking the sample (in case of recurrence).
- Pregnant patients before or during the duration of the study.
- Existence of serious or uncontrolled bacterial, fungal, or viral infections (type HPV, HIV, hepatitis) that, in the opinion of the principal investigator, could interfere with the participation of the patient in the study or in the evaluation of the study results.
- Any disease or medical condition that is unstable or may jeopardize patient safety and compliance in the study. For example: patients with an active history of other malignant tumours.
- Psychological, family, sociological or geographical situations that do not allow compliance with the protocol or the signing of informed consent.
- Patients vaccinated with mRNA vaccines in the week before surgery.
- Note: Control patients will have the same exclusion criteria as patients with tumour pathology
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites, 21 recruiting
- Not yet recruiting
Hospital General de Alicante
Alicante
Maria José Román, MD, +34 965 93 30 00, mjromangine@gmail.com
- Recruiting
Hospital Clinic de Barcelona
Barcelona
Berta Díaz, MD, +34 932 27 54 00, bertadiazfeijoo@gmail.com
- Not yet recruiting
Hospital del Mar Parc Salut
Barcelona
Gemma Mancebo, MD, +34 932 48 30 00, gemmamancebom@gmail.com
- Not yet recruiting
Complejo Hospitalario de Cartagena
Cartagena, Murcia
Sebastián Ortiz, MD, +34 968 12 86 00, sortizreina@yahoo.es
- Not yet recruiting
Hospital Universitario de Getafe
Getafe, Madrid
Belén Martín, MD, +34 916 83 93 60, belenmsalamanca@yahoo.com
- Not yet recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Jose Manuel Martínez, MD, +34 932 60 75 00, jmartinezgar@bellvitgehospital.cat
Sergi Fernández, MD, +34 932 60 75 00, sergi.sfg@gmail.com
- Not yet recruiting
Complejo Hospitalario Universitario Insular de Las Palmas
Las Palmas de Gran Canaria, Las Palmas
Miguel Andújar, MD, +34 928 44 40 00, mandsan@gobiernodecanarias.org
Octavio Arencibia, MD, +34 928 44 40 00, octavaren@hotmail.com
- Not yet recruiting
Hospital Universitario de León
León
Tatiana Cuesta, MD, +34 987 23 74 00, tguardio@hotmail.com
- Not yet recruiting
Hospital MD Anderson Cancer Center Madrid
Madrid
Javier De Santiago, MD, +34 912 77 72 20, jsantiagog@hotmail.es
- Not yet recruiting
Hospital Quirón Madrid
Madrid
Sara Iacoponi, MD, +34 914 52 19 00, saraiacoponi@hotmail.com
- Not yet recruiting
Hospital Universitario 12 de Octubre de Madrid
Madrid
Blanca Gil, MD, +34 913 90 80 00, blancalabacin@hotmail.com
Alvaro Tejerizo, MD, +34 913 90 80 00, tejerizo@hotmail.com
- Not yet recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid
Tirso Pérez, MD, +34 911 91 60 00, tirsoperezmedina@gmail.com
Augusto Pereira, MD, +34 911 91 60 00, augusto.pereira@salud.madrid.org
- Not yet recruiting
Hospital Regional Universitario de Málaga
Málaga
Jesús Jimenez, MD, +34 951 29 00 00, jjimenezme35426@hotmail.com
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca de Murcia
Murcia
Aníbal Nieto, MD, +34 968 36 95 00, anibal.nieto@um.es
- Not yet recruiting
Hospital Universitario de Son LLàtzer de Mallorca
Palma de Mallorca, Balearic Islands
Albert Reyes, MD, +34 871 20 20 00, areyes1@hsll.es
Cristina Martínez, MD, +34 871 20 20 00, mcmartinez@hsll.es
- Not yet recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre
Juan Carlos Muruzabal, MD, +34 848 42 22 22 ext. 59958, jc.muruzabal.torquemada@navarra.es
- Not yet recruiting
Hospital Virgen de la Macarena
Seville
Francisco Márquez, MD, +34 955 00 80 00, fmarquezma@gmail.com
- Recruiting
Hospital Virgen de la Salud de Toledo
Toledo
Sara Rojas, MD, +34 925 26 61 00, sararjsrz@gmail.com
- Not yet recruiting
Hospital Clínico Universitario de Valencia
Valencia
Aymara Mas, PhD, +34 961 97 35 00, amas@incliva.es
Octavio Burgues, MD, +34 961 97 35 00, octavioburgues@gmail.com
- Not yet recruiting
Hospital General Universitario de Valencia
Valencia
Juan Gilabert, MD, +34 963 13 18 00, juangilaeste@yahoo.es
Kristina Aghababyan, MD, +34 963 13 18 00, dra.kristina.agababyan@gmail.com
- Recruiting
Hospital Universitario y Politécnico La Fe de Valencia
Valencia
Santiago Domingo, MD, +34 961 24 43 50, santiago.domingo.delpozo@gmail.com
Javier Monleón, MD, +34 961 24 43 50, monlesancho@gmail.com
About this study
Official title: Prospective, Observational and Multicenter Case-control Study to Evaluate the Precision of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
The development of precise and non-invasive diagnostic methods is a priority in areas such as gynaecology and oncology, and above all in improving the health of those patients with a surgical indication for hysterectomy, laparoscopic or laparotomic myomectomy for diagnosis of uterine tumours. Indeed, in the absence of an accurate and objective preoperative diagnostic option, all patients with suspected benign tumours should be considered at risk for occult leiomyosarcoma.
Recently, the concept of "liquid biopsy" has emerged as a minimally invasive alternative to surgical biopsies for solid tumours with highly recurrent mutations, avoiding the sampling of tumour tissue before and after treatment. Generally, the liquid biopsy is obtained by taking a sample of blood or other body fluids, to provide tumour-specific information.
Read more
Based on these premises, a prospective, observational and multicentre case-control study is proposed, the objective of which is to evaluate the diagnostic precision (sensitivity, specificity, negative predictive value and positive predictive value) in the detection of molecular differences by liquid biopsy in patients with suspected myometrial tumour (leiomyoma / leiomyosarcoma).
Depending on the results of these analysis, the application of this technology could allow the differential diagnosis of the tumour in a non-invasive and objective way, as well as the development of biomarkers and effective targeted therapies in the treatment of leiomyosarcomas. Consequently, we would also be increasing our knowledge of tumour biology and associated pathologies in a clinical and therapeutic context.
Read the detailed description
Recently, the concept of "liquid biopsy" has emerged as a minimally invasive alternative to surgical biopsies. Generally, the liquid biopsy is obtained by taking a sample of blood or other body fluids, to provide tumour-specific information.
The use of technologies such as high-throughput sequencing or Next Generation Sequencing (NGS) could be an effective method for the detection of molecular differences from circulating genetic material in peripheral blood of patients with suspected myometrial tumour (leiomyoma / leiomyosarcoma), versus patients without tumour pathologies.
This is a prospective, multicentre, national biomedical case-control study aimed at patients with a surgical indication for hysterectomy or myomectomy due to the diagnosis of myometrial tumours (leiomyoma / leiomyosarcoma) according to standard clinical practice.
Once the study is approved by the Research Ethics Committee (CEI) of the Hospital, we will proceed to the recruitment and selection of those patients who meet the inclusion criteria.
After obtaining informed consent, peripheral blood will be collected from the candidate patient, prior to the surgery that the patient had already planned for medical indication in accordance with the usual clinical practice or, in the case of control patients, during an analysis or gynaecological consultation that was already planned to be performed by routine clinical practice. These samples will be sent to the Igenomix Foundation laboratories for molecular study.
Finally, and once both molecular and histological results are obtained, the precision of the determination of the molecular results will be compared with the "gold standard" in the diagnosis of myometrial tumours through two expert evaluators in pathological anatomy.
In this way, if the hypothesis raised is confirmed and the proposed objectives are achieved, we would be demonstrating the viability of a minimally invasive and precise preoperative diagnostic approach, based on the molecular characterization of leiomyoma and leiomyosarcoma.
When calculating the sample size for our study, we have considered the main objective, which is the validation of the test, comparing it with the "gold standard" of pathological anatomy. To calculate the sensitivity and specificity of the test, we would need a minimum of 200 LMS samples, 200 LM samples, and 200 control patient samples for validation.
It is intended to establish a cut-off point with a preliminary analysis in the first 30 patients (10 first patients from each group), in which the laboratory data are combined with those derived from the Pathological Anatomy (Gold Standard).
- Conditions
- Leiomyoma, Uterine, Leiomyosarcoma Uterus
- Being tested
- Collection of Leiomyoma samples, Collection of Leiomyosarcoma samples, Collection of control samples
- Keywords
- Leiomyoma (LM), Leiomyosarcoma (LMS), Sarcoma, Next Generation Sequencing, Circulating tumour cells (CTC), Plasma cell-free RNA (cfRNA)
- Medical subject headings
- Leiomyoma, Leiomyosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of Leiomyoma samplesProcedure or surgery
Also called Obtainment of blood sample (peripheral blood) and tumour tissue sample
Peripheral blood will be collected from the candidate patient with suspected myometrial tumours, prior to the surgery already planned form medical indication in accordance with routine clinical practice.
A sample of tumour tissue will be collected during surgery and sent to pathologists for diagnosis in accordance with the usual clinical practice. The tumour paraffin block/sections will be requested for the study only after the diagnosis.
Collection of Leiomyosarcoma samplesProcedure or surgery
Also called Obtainment of blood sample (peripheral blood) and tumour tissue sample
Peripheral blood will be collected from the candidate patient with suspected myometrial tumours, prior to the surgery already planned form medical indication in accordance with routine clinical practice.
A sample of tumour tissue will be collected during surgery and sent to pathologists for diagnosis in accordance with the usual clinical practice. The tumour paraffin block/sections will be requested for the study only after the diagnosis.
Collection of control samplesProcedure or surgery
Also called Obtainment of blood sample (peripheral blood)
Peripheral blood will be collected during an analysis or gynaecological consultation already planned by routine clinical practice. The sample will be sent to Igenomix for molecular analysis.
| Study group | Role | What they receive |
|---|---|---|
| Leiomyoma samples | Leiomyoma samples and peripheral blood samples obtained from women between 18 and 80 years with suspected myometrial tumour Receives: Procedure: Collection of Leiomyoma samples | |
| Leiomyosarcoma samples | Leiomyosarcoma samples and peripheral blood samples obtained from women between 18 and 80 years with suspected myometrial tumour Receives: Procedure: Collection of Leiomyosarcoma samples | |
| Control samples | Peripheral blood samples obtained from women between 18 and 80 years without suspected myometrial tumour Receives: Procedure: Collection of control samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic precision of uterine tumours at molecular level
Sensitivity, specificity, negative predictive value and positive predictive value of the molecular diagnosis of uterine tumours by liquid biopsy as a preoperative diagnosis, using pathological diagnosis as a "gold standard" to validate the molecular diagnosis.
Measured: 25 months
Secondary outcomes (3)
Concordance of Circulating tumour DNA / RNA versus DNA / RNA in tumour
Determine the concordance of circulating tumour DNA / RNA in plasma (ctRNA / ctDNA) versus the contribution of tumour tissue DNA / RNA in determining the diagnosis and histological subtype
Measured: 25 months
Inter-observer variability
Inter-observer variability in determining the histological diagnosis of uterine tumours in the analysis performed by pathologists
Measured: 25 months
Evaluation of Circulating tumour DNA / RNA profile for oncological outcome
Contribution of the plasma circulating tumour DNA / RNA profile (ctRNA / ctDNA) in determining the oncological outcome (survival, disease-free interval)
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study startSep 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiomyoma, UterineStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Simón, MD, PhD, Study chair, IgenomixAymara Mas, PhD, Principal investigator, Igenomix Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935333
- Sponsor's protocol ID
- IGX1-DTU-AM-21-03
- Acronym
- MYOSARCII
- Status last verified
- Sep 2021
- First submitted
- 21 Jun 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational and Multicenter Case-control Study to Evaluate the Precision of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
- ClinicalTrials.gov ID
- NCT04935333
- Acronym / sponsor ID
- MYOSARCII / IGX1-DTU-AM-21-03
- Conditions
- Leiomyoma, Uterine, Leiomyosarcoma Uterus
- Keywords
- Leiomyoma (LM), Leiomyosarcoma (LMS), Sarcoma, Next Generation Sequencing, Circulating tumour cells (CTC), Plasma cell-free RNA (cfRNA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Sep 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 23 Jun 2021 (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.
The development of precise and non-invasive diagnostic methods is a priority in areas such as gynaecology and oncology, and above all in improving the health of those patients with a surgical indication for hysterectomy, laparoscopic or laparotomic myomectomy for diagnosis of uterine tumours. Indeed, in the absence of an accurate and objective preoperative diagnostic option, all patients with suspected benign tumours should be considered at risk for occult leiomyosarcoma.
Recently, the concept of "liquid biopsy" has emerged as a minimally invasive alternative to surgical biopsies for solid tumours with highly recurrent mutations, avoiding the sampling of tumour tissue before and after treatment. Generally, the liquid biopsy is obtained by taking a sample of blood or other body fluids, to provide tumour-specific information.
Based on these premises, a prospective, observational and multicentre case-control study is proposed, the objective of which is to evaluate the diagnostic precision (sensitivity, specificity, negative predictive value and positive predictive value) in the detection of molecular differences by liquid biopsy in patients with suspected myometrial tumour (leiomyoma / leiomyosarcoma).
Depending on the results of these analysis, the application of this technology could allow the differential diagnosis of the tumour in a non-invasive and objective way, as well as the development of biomarkers and effective targeted therapies in the treatment of leiomyosarcomas. Consequently, we would also be increasing our knowledge of tumour biology and associated pathologies in a clinical and therapeutic context.
Detailed description
Recently, the concept of "liquid biopsy" has emerged as a minimally invasive alternative to surgical biopsies. Generally, the liquid biopsy is obtained by taking a sample of blood or other body fluids, to provide tumour-specific information.
The use of technologies such as high-throughput sequencing or Next Generation Sequencing (NGS) could be an effective method for the detection of molecular differences from circulating genetic material in peripheral blood of patients with suspected myometrial tumour (leiomyoma / leiomyosarcoma), versus patients without tumour pathologies.
This is a prospective, multicentre, national biomedical case-control study aimed at patients with a surgical indication for hysterectomy or myomectomy due to the diagnosis of myometrial tumours (leiomyoma / leiomyosarcoma) according to standard clinical practice.
Once the study is approved by the Research Ethics Committee (CEI) of the Hospital, we will proceed to the recruitment and selection of those patients who meet the inclusion criteria.
After obtaining informed consent, peripheral blood will be collected from the candidate patient, prior to the surgery that the patient had already planned for medical indication in accordance with the usual clinical practice or, in the case of control patients, during an analysis or gynaecological consultation that was already planned to be performed by routine clinical practice. These samples will be sent to the Igenomix Foundation laboratories for molecular study.
Finally, and once both molecular and histological results are obtained, the precision of the determination of the molecular results will be compared with the "gold standard" in the diagnosis of myometrial tumours through two expert evaluators in pathological anatomy.
In this way, if the hypothesis raised is confirmed and the proposed objectives are achieved, we would be demonstrating the viability of a minimally invasive and precise preoperative diagnostic approach, based on the molecular characterization of leiomyoma and leiomyosarcoma.
When calculating the sample size for our study, we have considered the main objective, which is the validation of the test, comparing it with the "gold standard" of pathological anatomy. To calculate the sensitivity and specificity of the test, we would need a minimum of 200 LMS samples, 200 LM samples, and 200 control patient samples for validation.
It is intended to establish a cut-off point with a preliminary analysis in the first 30 patients (10 first patients from each group), in which the laboratory data are combined with those derived from the Pathological Anatomy (Gold Standard).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leiomyoma samples | – | Procedure: Collection of Leiomyoma samplesLeiomyoma samples and peripheral blood samples obtained from women between 18 and 80 years with suspected myometrial tumour |
| Leiomyosarcoma samples | – | Procedure: Collection of Leiomyosarcoma samplesLeiomyosarcoma samples and peripheral blood samples obtained from women between 18 and 80 years with suspected myometrial tumour |
| Control samples | – | Procedure: Collection of control samplesPeripheral blood samples obtained from women between 18 and 80 years without suspected myometrial tumour |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women between 18 and 80 years old and with a body mass index (BMI) of 18.5-40.0 kg / m2, with suspected myometrial tumour (leiomyoma / leiomyosarcoma) based on clinical symptoms and imaging diagnosis, will be evaluated in their referral centre, verifying that they meet the inclusion / exclusion criteria to participate in the study. Women with the same age and BMI but without a uterine tumour will be used as control patients.
Key inclusion criteria (5 listed)
- Patients who voluntarily sign the informed consent approved by the Research Ethics Committee (CEI) after having been duly informed of the nature of the study, before carrying out any test related to it, knowing the potential risks, benefits and discomforts derived from their participation. Participants should be informed that they may leave the study at any time, without this entailing any consequence for their subsequent medical care.
- BMI = 18.5-40 kg / m2
- Age = 18-80 years
- Surgical indication according to usual clinical practice, due to suspicion of a tumour mass in the uterus, either primary (stages I-IV) or recurrence, but without prior chemotherapy or radiotherapy (at the time of primary diagnosis or prior to recurrence) .
- Note: Control patients will have the same inclusion criteria for BMI and age but without uterine tumour pathology.
Key exclusion criteria (8 listed)
- Patients who have participated in a clinical trial during the last 30 days unless it is approved by the sponsor as it does not interfere with the current study.
- Patients who have received chemotherapy or radiotherapy before taking the sample (in case of recurrence).
- Pregnant patients before or during the duration of the study.
- Existence of serious or uncontrolled bacterial, fungal, or viral infections (type HPV, HIV, hepatitis) that, in the opinion of the principal investigator, could interfere with the participation of the patient in the study or in the evaluation of the study results.
- Any disease or medical condition that is unstable or may jeopardize patient safety and compliance in the study. For example: patients with an active history of other malignant tumours.
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 |
|---|---|---|
| Collection of Leiomyoma samplesAlso: Obtainment of blood sample (peripheral blood) and tumour tissue samplePeripheral blood will be collected from the candidate patient with suspected myometrial tumours, prior to the surgery already planned form medical indication in accordance with routine clinical practice. A sample of tumour tissue will be collected during surgery and sent to pathologists for diagnosis in accordance with the usual clinical practice. The tumour paraffin block/sections will be requested for the study only after the diagnosis. | Procedure or surgery | Leiomyoma samples |
| Collection of Leiomyosarcoma samplesAlso: Obtainment of blood sample (peripheral blood) and tumour tissue samplePeripheral blood will be collected from the candidate patient with suspected myometrial tumours, prior to the surgery already planned form medical indication in accordance with routine clinical practice. A sample of tumour tissue will be collected during surgery and sent to pathologists for diagnosis in accordance with the usual clinical practice. The tumour paraffin block/sections will be requested for the study only after the diagnosis. | Procedure or surgery | Leiomyosarcoma samples |
| Collection of control samplesAlso: Obtainment of blood sample (peripheral blood)Peripheral blood will be collected during an analysis or gynaecological consultation already planned by routine clinical practice. The sample will be sent to Igenomix for molecular analysis. | Procedure or surgery | Control samples |
Primary outcome
Diagnostic precision of uterine tumours at molecular level
Time frame: 25 months
Sensitivity, specificity, negative predictive value and positive predictive value of the molecular diagnosis of uterine tumours by liquid biopsy as a preoperative diagnosis, using pathological diagnosis as a "gold standard" to validate the molecular diagnosis.
3 secondary outcomes
Concordance of Circulating tumour DNA / RNA versus DNA / RNA in tumour
Time frame: 25 months
Inter-observer variability
Time frame: 25 months
Evaluation of Circulating tumour DNA / RNA profile for oncological outcome
Time frame: 25 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- 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.
Carlos Simón, MD, PhD study chair
Igenomix
Aymara Mas, PhD principal investigator
Igenomix Foundation
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyoma, Uterine and Leiomyosarcoma Uterus, run by Igenomix at 21 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 8 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 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Gómez, BSc, MSc (+34 963905310, carlos.gomez@igenomix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic precision of uterine tumours at molecular level (time frame: 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2021.