Accuracy of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
MYOSARCII
Prospective, Observational and Multicenter Case-control Study to Evaluate the Precision of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
1 other identifier
observational
600
1 country
21
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedSeptember 10, 2021
September 1, 2021
1.7 years
June 21, 2021
September 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
25 months
Secondary Outcomes (3)
Concordance of Circulating tumour DNA / RNA versus DNA / RNA in tumour
25 months
Inter-observer variability
25 months
Evaluation of Circulating tumour DNA / RNA profile for oncological outcome
25 months
Study Arms (3)
Leiomyoma samples
Leiomyoma samples and peripheral blood samples obtained from women between 18 and 80 years with suspected myometrial tumour
Leiomyosarcoma samples
Leiomyosarcoma samples and peripheral blood samples obtained from women between 18 and 80 years with suspected myometrial tumour
Control samples
Peripheral blood samples obtained from women between 18 and 80 years without suspected myometrial tumour
Interventions
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.
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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) .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Igenomixlead
Study Sites (21)
Hospital Universitario de Son LLàtzer de Mallorca
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario Insular de Las Palmas
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Complejo Hospitalario de Cartagena
Cartagena, Murcia, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital General de Alicante
Alicante, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital del Mar Parc Salut
Barcelona, Spain
Hospital Universitario de León
León, Spain
Hospital MD Anderson Cancer Center Madrid
Madrid, Spain
Hospital Quirón Madrid
Madrid, Spain
Hospital Universitario 12 de Octubre de Madrid
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Clínico Universitario Virgen de la Arrixaca de Murcia
Murcia, Spain
Hospital Virgen de la Macarena
Seville, Spain
Hospital Virgen de la Salud de Toledo
Toledo, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario y Politécnico La Fe de Valencia
Valencia, Spain
Biospecimen
Blood samples to provide tumour-specific information from the circulating tumour cells (CTC) and or free tumour DNA / RNA (ctDNA / ctRNA) present in peripheral blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carlos Simón, MD, PhD
Igenomix
- PRINCIPAL INVESTIGATOR
Aymara Mas, PhD
Igenomix Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2021
First Posted
June 23, 2021
Study Start
September 1, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
September 10, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share