Preserving Fertility After Colorectal Cancer: The PREFACE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Sexual health history (Questionnaire)
研究概览
简要总结
The PREFACE Study is a prospective, longitudinal cohort study of reproductive health and clinical outcomes among individuals diagnosed with colorectal cancer between age 18 to 49 years.
详细描述
The Preserving Fertility After Colorectal Cancer (PREFACE) Study comprehensively investigates fertility, sexual health and clinical outcomes along the cancer care continuum among individuals diagnosed with colorectal cancer between age 18 to 49 years.
Patients are recruited prior to colorectal cancer therapy [baseline] and followed for up to 36 months after completion of first-course therapy (or 45 months after diagnosis for patients on maintenance therapy). Study timepoints are defined at: (i) completion of first-course treatment (or 9 months after diagnosis for patients on maintenance therapy [treatment]); (ii) and at 9, 18 and 36 month intervals thereafter [surveillance]. This cohort is enriched by a robust collection of biospecimens and data.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known diagnosis of colorectal cancer
- •Age 18 to 49 years at colorectal cancer diagnosis
- •Diagnosed by and/or consulting with a physician participating in the PREFACE Study
- •No prior history of colorectal cancer and/or colorectal cancer treatment
- •Mentally and physically able to consent and participate in the study
排除标准
- •Women who are pregnant at the time of colorectal cancer diagnosis
- •Prisoners
- •Unable to provide informed consent
- •Unable to read, write, or complete questionnaires in English
结局指标
主要结局
Sexual health history (Questionnaire)
时间窗: Baseline timepoint
Change(s) in reproductive health (Questionnaire)
时间窗: Baseline, treatment and multiple surveillance timepoints (up to 5 years)
Changes in sexual health (Questionnaire)
时间窗: Baseline, treatment and multiple surveillance timepoints (Up to 5 years)
Change(s) in serum hormonal markers
时间窗: Baseline, treatment and multiple surveillance timepoints (up to 5 years)
For female patients not taking oral contraceptive pills (OCPs), serum hormonal markers to be measured include: anti-Mullerian hormone (AMH), estrogens, sex hormone binding globulin (SHBG), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and androgens. For male patients, serum hormonal markers to be measured include: inhibin B, FSH, androgens, estrogens, SHBG and LH.
Disease-free survival
时间窗: Up to 5 years
Reproductive health history (Questionnaire)
时间窗: Baseline timepoint
Sexual health (Interview)
时间窗: 9 month post-treatment/Surveillance timepoint
次要结局
- Change(s) in health-related quality of life (Questionnaire)(At baseline, treatment and multiple surveillance timepoints (Up to 5 years))
- Physical activity (Accelerometer)(36 month post-treatment/Surveillance timepoint)
研究者
Andreana Holowatyj, PhD, MSCI
Sponsor Investigator
Vanderbilt-Ingram Cancer Center