Radical Trachelectomy for Women With Early Stage Cervical Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean scores for the General Health-Related Quality of Life (SF-12)
研究概览
简要总结
The goal of this research study is to learn about quality of life, sexual functioning, and symptoms in women who have undergone abdominal radical trachelectomy for cervical cancer.
This is an investigational study.
Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.
详细描述
Before Surgery:
If you agree to take part in this study, before you have the abdominal radical trachelectomy surgery, the following information will be recorded during one of your regular clinic visits:
- Your race and date of birth.
- Your complete medical and surgical history, including the date of your diagnosis and your diagnosis before surgery.
- Your weight, height, and body mass index.
During and After Surgery:
During and after surgery, the following information will be gathered from your medical record or you will be asked:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- •Patients with FIGO stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease
- •Patients must be suitable candidates for surgery
- •Patients who have signed an approved Informed Consent
- •Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease
- •Females older than 18 years who are undergoing radical trachelectomy
- •Women must be able to read and write in either Spanish or English
排除标准
- •Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- •Tumor size greater than 4 cm
- •FIGO stage II-IV disease
- •Patients with a history of pelvic or abdominal radiotherapy
- •Patients who are pregnant
- •Patients with contraindications to surgery
- •Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
结局指标
主要结局
Mean scores for the General Health-Related Quality of Life (SF-12)
时间窗: Follow up visits annually
Completed SF-12 questionnaires at baseline and at each follow-up visit (4-6 weeks, 6 months, 1 year, and annually for 4 more years)
次要结局
未报告次要终点