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Clinical trialNCT04935333UnknownObservational

Accuracy of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy

SponsorIgenomixEnrollment600Leiomyoma, UterineLeiomyosarcoma Uterus
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Spain
  • Hospital Universitario de Son Llàtzer de Mallorca

    Palma de Mallorca, Balearic Islands, Spain

    Not, yet, recruiting
  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, Spain

    Not, yet, recruiting
  • Complejo Hospitalario Universitario Insular de Las Palmas

    Las Palmas de Gran Canaria, Las Palmas, Spain

    Not, yet, recruiting
  • Hospital Universitario de Getafe

    Getafe, Madrid, Spain

    Not, yet, recruiting
  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, Spain

    Not, yet, recruiting
  • Complejo Hospitalario de Cartagena

    Cartagena, Murcia, Spain

    Not, yet, recruiting
  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, Spain

    Not, yet, recruiting
  • Hospital General de Alicante

    Alicante, Spain

    Not, yet, recruiting
  • Hospital Clinic de Barcelona

    Barcelona, Spain

    Recruiting
  • Hospital del Mar Parc Salut

    Barcelona, Spain

    Not, yet, recruiting
  • Hospital Universitario de León

    León, Spain

    Not, yet, recruiting
  • Hospital Md Anderson Cancer Center Madrid

    Madrid, Spain

    Not, yet, recruiting
  • Hospital Quirón Madrid

    Madrid, Spain

    Not, yet, recruiting
  • Hospital Universitario 12 de Octubre de Madrid

    Madrid, Spain

    Not, yet, recruiting
  • Hospital Clínico Universitario Virgen de la Arrixaca de Murcia

    Murcia, Spain

    Recruiting
  • Hospital Regional Universitario de Málaga

    Málaga, Spain

    Not, yet, recruiting
  • Hospital Virgen de la Macarena

    Seville, Spain

    Not, yet, recruiting
  • Hospital Virgen de la Salud de Toledo

    Toledo, Spain

    Recruiting
  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

    Not, yet, recruiting
  • Hospital General Universitario de Valencia

    Valencia, Spain

    Not, yet, recruiting
  • Hospital Universitario Y Politécnico la Fe de Valencia

    Valencia, Spain

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2021
Primary completion
31 May 2023
Completion
31 May 2023
Last update posted
10 Sept 2021
Registered enrollment
600
Registry id
NCT04935333

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.