Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04935333 |
| Other study ID # |
IGX1-DTU-AM-21-03 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2021 |
| Est. completion date |
May 2023 |
Study information
| Verified date |
September 2021 |
| Source |
Igenomix |
| Contact |
Carlos Gómez, BSc, MSc |
| Phone |
+34 963905310 |
| Email |
carlos.gomez[@]igenomix.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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).
