Identification of a MOLecuLar Signature Predicting Radiosensitivity in Locally Advanced Cervical Cancer Patients (LACC) Treated With Exclusive radiochemotherapY: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To test the performance of the molecular signature.
研究概览
简要总结
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.
详细描述
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. Several biomarkers of cervical cancer radioresistance have been previously studied and proposed; however, none of these has been the subject to further clinical studies and implemented into clinical practice. Recently, a panel of three protein coding genes (ANXA2-NDRG1-STAT1) differently expressed in radiosensitive LACC patients compared with the radioresistant ones, has been proposed by our institution. The population of LACC patients included in a previous study was treated with neo-adjuvant CTRT followed by radical surgery. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- •FIGO 2018 stage IIB and IIIC1[38]
- •Treatment with exclusive chemoradiation including brachytherapy
- •Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer
- •Has radiographically evaluable disease, measurable per RECIST 1.1
- •Negative pregnancy test
- •Adequate hematologic, renal, and hepatic functions, with following blood tests:
- •Neutrophils > 1500/μL Platelets > 100.000/ μL Hemoglobin > 9 g/dL Serum creatinine < 1.8 mg/dL Total bilirubin < 3 mg/ dL LDH < 3x normal value GOT < 3x normal value GPT < 3x normal value ALP < 3 x normal value
排除标准
- •Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc)
- •Neo-adjuvant treatment
- •Patients included in other clinical trials
- •Patients refusing to sign informed consent
- •Contraindications to radiotherapy
- •Contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic pelvic inflammatory disease, previous pelvic radiotherapy
结局指标
主要结局
To test the performance of the molecular signature.
时间窗: 60 months
To test the performance of the molecular signature in predicting response to exclusive CTRT in LACC patients.
次要结局
未报告次要终点