Actively Recruiting

Age: 18Years +
FEMALE
NCT07248878

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

IRCCS National Cancer Institute "Regina Elena"

Roma, RM, Italy, 00144

Actively Recruiting

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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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