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临床试验/NCT03689907
NCT03689907已完成不适用

Assessing the Predictive Potential of Early Chimerism Analysis Following Allogeneic Stem-Cell Transplant

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Characterize early lineage-specific chimerism profiles in allogeneic stem-cell transplant recipients

研究概览

简要总结

Allogeneic stem cell transplant (allo-SCT) is a common treatment for variety of blood cancers. To determine how many cells are from the donor after transplant, doctors complete a "chimerism analysis" or a test of participant cells to look at the DNA. Chimerism testing helps doctors predict graft rejection or recurrence of disease. Doctors at NCCC do chimerism testing routinely and it is usually done between 30 and 100 days after transplantation. The researchers believe that analyzing chimerism sooner than 30 days after transplant may help identify problems earlier, get patients treatment sooner, and increase the chances of a successful transplant.

The purpose of this study is to find out if doing chimerism testing earlier than the traditional approach is better for patient outcomes (about 14 days after transplantation rather than 30+ days). Information gained from this study can be used to help prevent some post-transplant complications such as graft loss, graft-versus-host disease, or even relapse for future patients.

Also, the researchers hope to learn more about chimerism testing of cells of patients with haploidentical donors (donors who are only a "half-match" - such as a parent or child of the recipient), because there have not been many chimerism analysis studies done in this population.

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
All
接受健康志愿者
否

入选标准

  • •All patients will have been cleared by a Transplant Attending to undergo allogeneic stem cell transplant

排除标准

  • •Patients undergoing a second allogeneic stem cell transplant or beyond

结局指标

主要结局

Characterize early lineage-specific chimerism profiles in allogeneic stem-cell transplant recipients

时间窗: 14 or 15 days post-transplant

Our method of chimerism analysis is dependent on baseline DNA samples of pre-transplant donor and recipient, then serial assessment of polymorphic short tandem repeats (STRs) to specifically characterize the source (donor vs recipient) of DNA extracted from our patients' leukocytes at day +14/15 after allogeneic stem cell transplant. First, DNA is extracted from the buffy coat layer of an EDTA blood sample, then PCR reactions using STR markers are prepared, and the differently sized fluorescent PCR products are then assessed on a genetic analyzer. An assessment of the relative amounts of donor and recipient chimerism can then be determined from the analyzer output, based on peak height and area. The discreet leukocyte lineages are then isolated by cell separation, and DNA is isolated from these purified fractions and assessed as for whole blood.

次要结局

  • Correlate early chimersim profiles with donor chimerism(Day +30-post transplant)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John M. Hill, Jr., MD

Director, Allogeneic Bone Marrow Transplant Program

Dartmouth-Hitchcock Medical Center

研究点 (1)

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