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

NCT07248878 | Recruiting

• 1 other identifier: RS315/IRE/25
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer Stage IB2; Cervical Cancer Stage IIa; Cervical Cancer Stage IB; Cervical Cancer Stage IIIA

Outcome Measures

Primary Outcomes (1)

• RNA-sequencing

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Università di Verona, AOUI Verona Dipartimento di Ostetricia e Ginecologia: collaborator

Study Sites (1)

IRCCS National Cancer Institute "Regina Elena"

Roma, RM, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, tissue sample, vaginal swab

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Antonella Savarese, Medical Doctor

CONTACT

+39 0652666919; antonella.savarese@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: March 26, 2025
• Primary Completion: March 26, 2026
• Study Completion (Estimated): March 26, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

IT (1)