Clinical trial · Observational
Accuracy of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
Prospective, Observational and Multicenter Case-control Study to Evaluate the Precision of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma, Uterine | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Leiomyosarcoma Uterus | Uterine Corpus Leiomyosarcoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of control samples | Procedure | — | UNRESOLVED |
| Collection of Leiomyoma samples | Procedure | — | UNRESOLVED |
| Collection of Leiomyosarcoma samples | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Leiomyoma samples
- description
- Leiomyoma samples and peripheral blood samples obtained from women between 18 and 80 years with suspected myometrial tumour
- interventionNames
- Procedure: Collection of Leiomyoma samples
- label
- Leiomyosarcoma samples
- description
- Leiomyosarcoma samples and peripheral blood samples obtained from women between 18 and 80 years with suspected myometrial tumour
- interventionNames
- Procedure: Collection of Leiomyosarcoma samples
- label
- Control samples
- description
- Peripheral blood samples obtained from women between 18 and 80 years without suspected myometrial tumour
- interventionNames
- Procedure: Collection of control samples
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available