A Real-world Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on Molecular Profiling and Multidisciplinary Team Consultation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- the overall response rate
研究概览
简要总结
This is a non-interventional, real-world study divided into two parts: a retrospective study and a prospective study.
The main question it aims to answer is:
Will genomic sequencing and molecular tumor boards lead to clinical responses in patients with recurrent ovarian, cervical, or endometrial cancer? The retrospective arm will analyze data from patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) who underwent multidisciplinary consultations at our institution from January 2022 onward. Data collected will include tumor tissue genomic sequencing results, medical histories, multidisciplinary consultation recommendations, and subsequent treatment courses. This analysis will examine the implementation and clinical efficacy of personalized targeted therapies guided by molecular tumor profiling and multidisciplinary consultation.
The prospective arm will enroll 200 patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) referred for multidisciplinary consultation. Tumor tissue and blood samples will undergo next-generation sequencing (NGS) to determine molecular tumor profiles. A multidisciplinary expert panel will formulate individualized treatment strategies based on these profiles, patient clinical data, and treatment history. Attending physicians will determine the final treatment plan, integrating multidisciplinary recommendations with patient preferences, comorbidity considerations, drug toxicity assessments, insurance coverage for off-label medications, and the availability of investigational drug trials. This arm aims to observe and evaluate the clinical efficacy of personalized treatment plans developed through molecular tumor profiling and multidisciplinary consultation.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent ovarian, cervical, or endometrial cancer referred for multidisciplinary consultation by a gynecological oncologist;
- •Presence of at least one evaluable lesion;
- •Willingness to participate in multidisciplinary consultation;
- •Age 18 years or older;
- •Sufficient tumor tissue for next-generation sequencing (NGS) with a tumor content greater than 32%;
- •Informed consent provided by the participant, indicating understanding of the study procedures and willingness to participate.
排除标准
- •Patients with concurrent malignancies;
- •Pregnant patients.
结局指标
主要结局
the overall response rate
时间窗: an assessment was performed at the end of Cycle 2 or Cycle 3 or Cycle 4 (each cycle is 21-28 days) according to the actual situation
the overall response rate (ORR) by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans
次要结局
- the progression free survival (PFS)(2 years)
- the overall survival (OS)(2 years)
研究者
Jihong Liu
professor
Sun Yat-sen University
