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Clinical Trials in Italy / NCT07248878
Recruiting Observational

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

NCT07248878 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-03-26
Last updated
2025-11-25

Condition(s) studied

Cervical Cancer Stage IB2Cervical Cancer Stage IIaCervical Cancer Stage IBCervical Cancer Stage IIIA

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS National Cancer Institute "Regina Elena" Roma RM Recruiting

More Regina Elena Cancer Institute trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07248878 on ClinicalTrials.gov ↗ ← All trials in Italy