Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy (Cervical organ)

November 18, 2025 updated by: Regina Elena Cancer Institute

A meta-analysis showed that neoadjuvant chemotherapy followed by radical hysterectomy reduces the risk of mortality by 35% compared to radiotherapy alone, with a 14% increase in five-year survival. Unfortunately, however, approximately 30% of patients undergoing neoadjuvant chemotherapy are referred for adjuvant radiotherapy or chemoradiotherapy due to the presence of high recurrence risk factors after surgery, which results in a bi- or tri-modal treatment with very serious consequences in terms of toxicity. Infact, approximately 20% of patients treated with radiotherapy experience vaginal discomfort up to 3 years after completing treatment, with significant consequences for the women's quality of life. Therefore, on the one hand, it would be appropriate to identify new drugs that synergize with chemotherapy, reducing the need for adjuvant radiation; on the other, it could be useful to identify patients who could truly benefit from neoadjuvant treatment. To do this, it is necessary to have ex vivo biological models capable of simulating the complexity of the tumor environment and that can be used as a tool to investigate tumor response to specific treatments.

In this context, tumor organoids represent ideal alternative in vitro models, capable of preserving the characteristics of the original tumors, including their architecture and cell types present. They can be used as avatars for the selection of specific anticancer therapies and for the creation of patient biobanks.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study involves the prospective recruitment of patients with suspected cervical cancer who undergo a biopsy at the Gynecological Oncology Unit of the Regina Elena Cancer Institute in Rome. Patients will be given an explanation, reading, and signing of the informed consent form.

They will undergo a biopsy and tissue sampling according to clinical practice during colposcopy.

A vaginal swab and blood sample will be taken before the biopsy. The tissue collected during the biopsy will be analyzed, and cases of cervical cancer with FIGO IB2, IB3-IIA2, and IIA1 or FIGO III will be selected for organoid culture.

If the analyzed tissue is negative for the presence of cancer (approximately 2% of cases), the patient will be considered a screening failure.

A portion of the tissue (approximately 1 cm) and the collected blood, only if their availability and adequacy are guaranteed for the purpose of conserving suitable material in an archive, will be sent to the IRE Translational Oncology Research Laboratories and used for the generation of organoids. The vaginal swab will be sent to the ISG Microbiology and Virology Laboratory for microbiome analysis.

The blood, tissue, and swab collected for patients who fail to respond will remain available to the IRE Anatomy Pathology Unit or will be biobanked for future studies related to this project.

Study Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00144
        • Recruiting
        • IRCCS National Cancer Institute "regina Elena"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a suspected diagnosis of cervical cancer for whom a biopsy is indicated

Description

Inclusion Criteria:

  • female over 18 years of age;
  • suspected diagnosis of cervical cancer for which a biopsy is indicated according to standard clinical practice;
  • Informed consent (study participation and data processing) given in writing personally and/or through the legal representative/guardian/support administrator/witness, before any study-specific procedure is performed.

Exclusion Criteria:

  • previous malignancies;
  • previous systemic treatments;
  • previous antibiotic treatment before surgery. Any antibiotic treatment must be stopped at least 3 weeks before surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with suspected cervical cancer
Patients with a suspected diagnosis of cervical cancer for whom a biopsy is indicated according to clinical practice who undergo a biopsy at the Gynecological Oncology Unit of the Regina Elena Cancer Institute in Rome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNA-sequencing
Time Frame: 36 months

DNA for WES profiling will be extracted from biopsy tissue and PDOs using the AllPrep kit.

The DNA/RNA/miRNA Universal Kit will be used to prepare organoid cultures.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Collaborators

Università di Verona, AOUI Verona Dipartimento di Ostetricia e Ginecologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2025

Primary Completion (Estimated)

March 26, 2026

Study Completion (Estimated)

March 26, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS315/IRE/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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