Generation of Endometrial Carcinoma Organoids
ConditionEndometrial Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRegina Elena Cancer Institute
About this trial
A prospective pilot genetic study to evaluate the feasibility of generating organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice. Samples will be collected from collaborating extramural facilities, with the aim of analyzing the impact of transport on tissue viability and the success of organoid culture. This study is for exploratory purposes only, without altering the diagnostic and therapeutic pathways of the participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years;
Patients with a histological diagnosis of: endometrial cancer, endometrioid histology, any stage of disease (FIGO I-IV), recurrence/metastasis from endometrial endometrioid cancer, and candidates for surgery and/or hysterectomy;
Written informed consent (study participation and data processing) must be obtained in person and/or through a legal representative/guardian/support administrator/witness, before any study-specific procedure is performed.
Disqualifiers
Comorbidities not controlled with adequate medical therapy;
Endometrial cavity infections (pyometra);
Synchronous tumors;
Neoadjuvant treatments;
Trial population
Patients with a histological diagnosis of endometrioid endometrial cancer at any stage of the disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice
GeneticCreation of endometrial carcinoma organoids from tumor tissue from extramural structures, verifying the feasibility of organoid generation. Evaluate the impact of sample transport and storage conditions on the success of the process, considering the challenges associated with preserving tissue integrity.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients with endometrial cancer of the endometrioid histology at any stage of the disease.1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of organoid generation
The feasibility of generating endometrial carcinoma organoids from tumor tissue will be assessed by analyzing the success rate in organoid generation, expressed as a percentage.
Time frame
42 monthsSponsors and contacts
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Regina Elena Cancer Institute
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborator
Source ClinicalTrials.gov