Growing cervical cancer organoids from diagnostic biopsy samples
Official title: Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
Run by Regina Elena Cancer Institute · NCT07248878 · Data updated 2026-11-12
We will try to grow tiny, patient-specific tumor organoids from biopsy tissue collected during diagnostic biopsy in adults with suspected stage IB2–IIIA cervical cancer so labs can test treatments on them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 24 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | March 26, 2025 |
| Main results expected | March 26, 2026 |
| Study ends | March 26, 2028 |
| Registry record updated | November 25, 2025 |
| Trial ID | NCT07248878 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women with suspected cervical cancer scheduled for diagnostic biopsy who have not had prior malignancies, prior systemic cancer treatments, or recent antibiotic use are ideal candidates.
✕Probably not a fit
Patients whose biopsy is negative for cancer, whose samples are inadequate for organoid growth, or who have recent antibiotics or prior systemic cancer therapy are unlikely to benefit from organoid generation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective pilot enrolls adults undergoing diagnostic cervical biopsy at the Regina Elena Cancer Institute and collects biopsy tissue, a vaginal swab, and blood. Tissue from confirmed FIGO IB2–IIA/III cases will be sent to translational labs to attempt organoid generation, while swabs will be analyzed for the vaginal microbiome. Cases with negative or inadequate tissue will be considered screening failures and collected material may be biobanked for future studies. The study is observational and focuses on creating biological models and linked samples and data rather than testing any experimental therapy.
Why it matters
Potential benefit: If successful, organoids could enable personalized lab testing to identify drugs that boost chemotherapy response and reduce the need for adjuvant radiation, potentially lowering long-term toxicity.
How similar studies have gone: Organoids have been successfully created for several tumor types and used for preclinical drug testing, but application to guide treatment in cervical cancer is still experimental and at a pilot stage.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
IRCCS National Cancer Institute "Regina Elena"
Roma, Rm, Italy Recruiting
Study contacts
- Study coordinator: Antonella Savarese, Medical Doctor
- Email: antonella.savarese@ifo.it
- Phone: +39 0652666919
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.