NCT07248878 Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
| NCT ID | NCT07248878 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Cervical Cancer Stage IB2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2026-03-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2025-03-26 with a primary completion date of 2026-03-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07248878 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancer Stage IB2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07248878 currently recruiting?
Yes, NCT07248878 is actively recruiting participants. Contact the research team at antonella.savarese@ifo.it for enrollment information.
Where is the NCT07248878 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07248878 clinical trial?
NCT07248878 is sponsored by Regina Elena Cancer Institute. The trial plans to enroll 24 participants.
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