Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagn
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 radiot
| Condition(s) | Cervical Cancer Stage IB2, Cervical Cancer Stage IIa, Cervical Cancer Stage IB, Cervical Cancer Stage IIIA |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 synergiz |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Regina Elena Cancer Institute |
| Locations | Roma, RM, Italy |
| Start date | 2025-03-26 |
| NCT ID | NCT07248878 |
| Official listing | https://clinicaltrials.gov/study/NCT07248878 |