Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04935333
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04935333
Study Brief:
Protocol Section:
NCT04935333