Gonadotropin Releasing Hormone Agonist (GnRHa) Therapy and Ovarian Preservation in Pediatric and Adolescent Subject Receiving Chemoradiation Therap
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- Ovarian Reserve - AMH
研究概览
简要总结
This is a prospective case control study. Participants will be enrolled as case subjects or control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The chemotherapeutic regimens will be determined per standard of care. Participants will receive GnRHa (Lupron) as standard of care for menstrual suppression. Blood draws and pelvic ultrasound at baseline, 6 months and 12 months post completion of chemotherapy are the interventions. The duration of the study will be approximately 12 months.The study time includes the time necessary for completion of most cancer treatments in this population, which approximates 8-12 months, and time to allow complete excretion of the Lupron from the systemic circulation with reliable testing of the hypothalamic pituitary ovarian (H-P-O) axis. The results of the study will be used to guide a larger study evaluating the efficacy of gonadotropin releasing hormone agonist (GnRHa) as ovarian preservation therapy in young subjects receiving chemoradiation.
详细描述
This study will not utilize a survey or questionnaire. Data will be collected via chart review and direct subject and/or guardian interviews.
Electronic medical records will be accessed only by approved clinical and research personnel to retrieve clinical and laboratory data.
At the initial visit, the following will be performed and collected on all subjects: Body Mass Index; age at thelarche; age at menarche; Tanner staging for breast and pubic hair; oncologic diagnosis; date of oncologic diagnosis; chemoradiation therapy treatment regimen; date of initiation of chemoradiation therapy; pre-treatment ovarian function blood tests; date GnRHa therapy initiated; a pelvic ultrasound will be performed to assess ovarian volumes and antral follicle count.
The subject will receive GnRHa 11.25 mg every 2 months until completion of chemotherapy, which is consistent with current clinical care at the University of Kentucky Medical Center (UKMC).
Study blood tests to evaluate ovarian function and pelvic ultrasound will be performed at three time points: immediately prior to initiation of GnRHa therapy and 6 and 12 months after chemoradiation therapy is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Receiving chemoradiation therapy
- •Documented ovarian function
- •Require menstrual suppression with GnRHa during chemoradiation therapy
- •Patients at the University of Kentucky, Norton Healthcare or Cincinnati Children's Hospital Medical Center
排除标准
- •Under 8 years of age and older than 19 years of age
- •Unable to provide consent or assent
研究组 & 干预措施
Cases
Participants who will receive gonadotoxic chemoradiation therapies to include the alkylating agents, heavy metals and plant alkaloids as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions.
干预措施: Blood draw (Procedure)
Cases
Participants who will receive gonadotoxic chemoradiation therapies to include the alkylating agents, heavy metals and plant alkaloids as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions.
干预措施: Pelvic Ultrasound (Procedure)
Controls
Participants who will receive chemoradiation therapies presumed to be low risk for gonadotoxicity as determined by the literature and the patient's oncolologist as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions.
干预措施: Blood draw (Procedure)
Controls
Participants who will receive chemoradiation therapies presumed to be low risk for gonadotoxicity as determined by the literature and the patient's oncolologist as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions.
干预措施: Pelvic Ultrasound (Procedure)
结局指标
主要结局
Ovarian Reserve - AMH
时间窗: 12 months post completion of chemotherapy
Assess AMH change from baseline to 12 months.
Ovarian Reserve - Menstrual function
时间窗: 6 months post completion of chemotherapy
Assess menstrual function change from baseline to 6 months.
Ovarian Reserve - FSH
时间窗: 12 months post completion of chemotherapy
Assess FSH change from baseline to 12 months.
次要结局
- Ovarian Reserve - Agreement of AMH and AFC(Pre-GnRHa therapy, 6 months post and 12 post completion of chemotherapy)