Growing cervical cancer organoids from diagnostic biopsy samples
Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
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 |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT07248878 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, RM
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.