FERtility After Therapy With Intensive Lymphoma in Young Women: LNH-03 1B, LNH-03 2B, LNH-07 3B, GAINED Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 27
- 主要终点
- Study fertility by evaluating the rate of spontaneous pregnancy (with live-born children) in women (≤ 38 years) treated for diffuse large B-cell lymphoma in 4 LYSA clinical trials.
研究概览
简要总结
The FERTILE study is a retrospective cohort study evaluating fertility after intensive treatment with RCHOP14/RCHOP21 or ACVBP in young patients with diffuse large B-cell lymphoma treated in clinical trials conducted by the LYSA group and still alive several years after the end of the trial.
详细描述
The FERTILE study is a retrospective cohort study evaluating fertility after intensive treatment with RCHOP14/RCHOP21 or ACVBP in young patients (≤ 38 years) with diffuse large B-cell lymphoma treated in 4 clinical trials conducted by the LYSA group and still alive several years after the end of the trial.
Chemotherapy treatments used to treat diffuse large B-cell lymphoma in women of childbearing age may cause loss of fertility.
There are few studies dedicated specifically to women treated for non-Hodgkin's lymphoma, particularly in the context of intensive CHOP-based regimens (R-CHOP14/R-CHOP21/R-ACVBP). These studies do not provide any details on the type of treatment and the clinical characteristics of the patients. It is in this context that we propose the FERTILE study.
This study is based on the collection and reuse of data already available in the LNH03-1B, LNH03-2B, LNH07-3B and GAINED clinical trials such as the age of the patients, the treatments, the diagnosis. The results of hormonal assessments and fertility tests (endovaginal ultrasound) will also be consulted in the medical file.
In addition, a questionnaire concerning fertility will be proposed by the physician-investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subjects are women
- •Participation in one of the following clinical trials: LNH 03 1B or LNH 03 2B or LNH 07 3B or GAINED
- •Age at initial diagnosis between 18 years and 38 years inclusive, which has allowed their inclusion in the clinical trial
- •Treated with R-ACVBP or R-CHOP14/R-CHOP21 in these clinical trials
- •No relapse of their diffuse large B-cell lymphoma
- •Possible use of stem cell transplantation during clinical trials
- •Subjects are still alive today
排除标准
- •Subjects died
- •Subjects lost to follow-up
结局指标
主要结局
Study fertility by evaluating the rate of spontaneous pregnancy (with live-born children) in women (≤ 38 years) treated for diffuse large B-cell lymphoma in 4 LYSA clinical trials.
时间窗: Day 0 from date of questionnaire signature
The fertility rate: spontaneous pregnancy rate (with live births) among young women who wish to have children.
次要结局
- Identify the predictive factors associated with pregnancy success after intensive chemotherapy treatment.(Day 0 from date of questionnaire signature)
- Identify predictive factors associated with gonadal dysfunction.(Day 0 from the questionnaire signature)
- Study the different clinical practices concerning the preservation of fertility in LYSA sites.(Day 0 from date of questionnaire signature)