Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- RNA-sequencing
研究概览
简要总结
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.
详细描述
The study involves the prospective recruitment of patients with suspected cervical cancer who undergo a biopsy at the Gynecological Oncology Unit of the Regina Elena Cancer Institute in Rome. Patients will be given an explanation, reading, and signing of the informed consent form.
They will undergo a biopsy and tissue sampling according to clinical practice during colposcopy.
A vaginal swab and blood sample will be taken before the biopsy. The tissue collected during the biopsy will be analyzed, and cases of cervical cancer with FIGO IB2, IB3-IIA2, and IIA1 or FIGO III will be selected for organoid culture.
If the analyzed tissue is negative for the presence of cancer (approximately 2% of cases), the patient will be considered a screening failure.
A portion of the tissue (approximately 1 cm) and the collected blood, only if their availability and adequacy are guaranteed for the purpose of conserving suitable material in an archive, will be sent to the IRE Translational Oncology Research Laboratories and used for the generation of organoids. The vaginal swab will be sent to the ISG Microbiology and Virology Laboratory for microbiome analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •previous malignancies;
- •previous systemic treatments;
- •previous antibiotic treatment before surgery. Any antibiotic treatment must be stopped at least 3 weeks before surgery.
结局指标
主要结局
RNA-sequencing
时间窗: 36 months
DNA for WES profiling will be extracted from biopsy tissue and PDOs using the AllPrep kit. The DNA/RNA/miRNA Universal Kit will be used to prepare organoid cultures.
次要结局
未报告次要终点
