Recruiting

NCT Number: NCT07248878

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

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.

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Key information

Conditions

Cervical Cancer Stage IB2 Cervical Cancer Stage IB Cervical Cancer Stage IIIA Cervical Cancer Stage IIa Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS National Cancer Institute "Regina Elena"

Roma, RM, 00144, Italy

Location status: Recruiting

Location contact

Antonella Savarese, Medical Doctor

CONTACT

[email protected]

+39 0652666919

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

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.

Study contacts

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

Antonella Savarese, Medical Doctor

CONTACT

[email protected]

+39 0652666919

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Collaborators

Università di Verona, AOUI Verona Dipartimento di Ostetricia e Ginecologia

Registry information

Acronym: Cervical organ

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2028
First posted: Nov 25, 2025
Registry last updated: Nov 25, 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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