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RECRUITING
NCT07248878

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

Sponsor: Regina Elena Cancer Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

24

Start Date

2025-03-26

Completion Date

2028-03-26

Last Updated

2025-11-25

Healthy Volunteers

No

Locations (1)

IRCCS National Cancer Institute "Regina Elena"

Roma, RM, Italy