RecruitingNCT07248878

Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy


Sponsor

Regina Elena Cancer Institute

Enrollment

24 participants

Start Date

Mar 26, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a research study that collects small tissue samples (biopsies) from women with suspected cervical cancer in order to grow them in a laboratory as "organoids" — tiny 3D models of the tumor. These organoids help researchers study cancer behavior and test potential treatments outside the body. **You may be eligible if...** - You are a woman aged 18 or older - You have a suspected diagnosis of cervical cancer that requires a biopsy as part of standard care - You are willing to provide written informed consent **You may NOT be eligible if...** - You have a prior history of any cancer (other than the current suspected cervical cancer) - You have previously received any systemic treatment for cancer - You received antibiotics within the past 3 weeks before your biopsy or surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

IRCCS National Cancer Institute "Regina Elena"

Roma, RM, Italy

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NCT07248878


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