Actively Recruiting
Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
Led by Regina Elena Cancer Institute · Updated on 2025-11-25
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
R
Regina Elena Cancer Institute
Lead Sponsor
U
Università di Verona, AOUI Verona Dipartimento di Ostetricia e Ginecologia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female over 18 years of age
- Suspected cervical cancer diagnosis requiring a biopsy according to standard clinical practice
- Provided written informed consent for study participation and data processing
You will not qualify if you...
- History of previous malignancies
- Previous systemic cancer treatments
- Antibiotic treatment within 3 weeks before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS National Cancer Institute "Regina Elena"
Roma, RM, Italy, 00144
Actively Recruiting
Research Team
A
Antonella Savarese, Medical Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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