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NCT Number: NCT07258186

Generation of Endometrial Carcinoma Organoids

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS National Cancer Institute "Regina Elena"

Roma, 00144, Italy

Location status: Recruiting

Location contact

Giovanni Blandino, Medical Doctor

CONTACT

[email protected]

+39 0652662911

About this study

The prospective study involves the collection and freezing of biological samples at the IRE Translational Oncology Research Unit. Collecting and using:

  • Fresh tissue: tumor and peritumor tissue from the same patient, obtained surgically at participating centers, will be collected under the supervision of a dedicated pathologist, sent to the IRE Translational Oncology Research Unit, and frozen. The collected tissue will be processed and used to perform gene expression profiling using RNAseq and WES and to generate organoids.
  • Blood (Serum and PBMCs) - A blood sample (EmoT0) will also be collected for each patient before surgery. This sample will be used to prepare serum for aliquoting/freezing, and peripheral blood mononuclear cells (PBMCs). These will also be sent, frozen, and stored at the IRE Translational Oncology Research Unit. These will be used to evaluate the organoids' response to immunotherapy treatments through coculture experiments.

Only biological material whose availability and suitability are guaranteed will be used to archive appropriate material as required by law. It will then be sent to the research laboratories of the IRE Translational Oncology Research Unit and will be used for genomic analysis and the generation of organoids.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Comorbidities not controlled with adequate medical therapy;
  • Endometrial cavity infections (pyometra);
  • Synchronous tumors;
  • Neoadjuvant treatments;
  • Previous radiation treatments to the pelvic region.

Treatment and study plan

Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice

Genetic

Creation 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.

Primary outcomes

  1. Feasibility of organoid generation

    Time frame: 42 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Blandino, Medical Doctor

CONTACT

[email protected]

+39 0652662911

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

Registry information

Official study title

Feasibility Study of the Generation of Endometrial Carcinoma Organoids From Tumor Samples Transferred From Extramural Facilities

Acronym: organoids endo

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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