Improvement of Women's Health After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice.
研究概览
简要总结
The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women.
详细描述
The invetigators plan to recruit 100 women who will be evaluated 9 times over a period of 2 years (before allograft, at + 3 months, +6 months, +9 months, +12 months, +15 months, +18 months, +21 months, and +24 months +/- 14 days). If a new diagnosis of cGVHD is made between 2 visits, an additional gynecological examination will be performed.
Visits by the Hôpital Maisonneuve-Rosemont Hospital transplant team will include a physical examination to assess for the presence of cGVHD using the NIH criteria. The FACT-BMT quality of life questionnaire will also be completed before the allograft, at 3 months and 6 months after transplant. If cGVHD is diagnosed, the participants will also have to complete two questionnaires specific to cGVHD (Lee Scale for cGVHD, Patient self-assessment of cGVHD) at diagnosis and then at + 6, +12, +18 and +24 months from day 0 of allograft.
Assessments by CHUM gynecologists will take place before the allograft, then at +3, +6, +12, +18 and +24 months from day 0 of the allograft and will include: a vulvar/vaginal examination, a sample for HPV testing and sexual health questionnaires to be completed (Personal assessment of intimacy within relationships - PAIR, Female Sexual Function Index - FSFI , Female Sexual Distress Scale-Revised - FSDS-R).
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
- •All women aged 18 and over who will receive a first allogeneic HSCT (bone marrow, peripheral blood stem cells from a related, unrelated (including cord blood) or haploidentical donor) at the CIUSSS-EMTL. Recruitment will begin when the project receives ethical approval. Recruitment period will be of 2 to 3 years.
排除标准
- •Those who receive a second HSCT allograft.
- •Those who receive an autologous transplant.
- •Inability to give informed consent.
- •Unable to communicate in French or English.
- •Any other reason which, according to the investigators, makes it preferable for a patient not to participate.
结局指标
主要结局
Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice.
时间窗: From -1 month of transplant until +24 months after.
Prospective history, physical exam with focus on cGVHD.
次要结局
- Evaluate sexual function of allografted women(At screening and 6,12,18 and 24 months post transplant)
- Measure the incidence and prevalence of HPV infection(3, 6 and 12 months post transplant)
- Evaluate the quality of life (QoL) of allografted women(At screening and 3, 6, 12, 18 and 24 months post transplant)
- Evaluate intimacy within relationships of allografted women(At screening and 6,12,18 and 24 months post transplant)
- Evaluate sexual distress of allografted women(At screening and 6,12,18 and 24 months post transplant)
- Evaluate genital cGVHD treatment response(From diagnosis until 24 months post transplant)
- Evaluate the frequency of premature ovarian failure(3, 6 and 12 months post transplant)