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.

NCT Number	NCT07248878
Lead Sponsor	Regina Elena Cancer Institute Collaborators: Università di Verona, AOUI Verona Dipartimento di Ostetricia e Ginecologia
Conditions	Cervical Cancer Stage IB2, Cervical Cancer Stage IIa, Cervical Cancer Stage IB, Cervical Cancer Stage IIIA
Enrollment	24 participants
Start Date	2025-03-26
Primary Completion	2026-03-26 (estimated)
Study Completion	2028-03-26 (estimated)
Updated on ClinicalTrials.gov	2025-11-25