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临床试验/NCT04745416
NCT04745416已完成不适用

Clinical Characteristics of Patients With Hematological Cancer Diagnosed and Severe Acute Respiratory Syndrome Coronavirus 2 Infection at the Hospital de Alta Especialidad de Ixtapaluca and the Hospital General de México "Dr. Eduardo Liceaga"

Hospital General de Mexico2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月1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
30
试验地点
2
主要终点
Overall survival

研究概览

简要总结

The purpose of this study is to describe the main clinical characteristics of patients with de novo acute lymphoblastic leukemia treated inside the third level hospitals converted to Coronavirus disease 2019 (COVID-19) attention for the metropolitan area of Mexico City.

详细描述

Retrospective, observational study in patients with diagnosis of acute lymphoblastic leukemia, according to the criteria of the World Health Organization, from April 2020 to December 2020. Patients was cared for in the hematology department of the Hospital Regional de Alta Especialidad de Ixtapaluca or the Hospital General de México. Both hospitals have been assigned as Coronavirus disease 2019 (COVID-19) hospitals, limiting the access, number of outpatient visits and chemotherapy protocols.

Real-time polymerase chain reaction (RT-PCR) test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was performed for patients with respiratory symptoms or history of contact with suspected / confirmed cases of COVID-19 Upon having a positive RT-PCR test, patients were transferred to a respiratory isolation unit to continue their recovery. Support treatment for COVID-19 was based on local considerations.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization.

排除标准

  • Age less than 18 years
  • Incomplete medical records

结局指标

主要结局

Overall survival

时间窗: through study completion, an average of 1 year

Number of relapses

时间窗: through study completion, an average of 1 year

Cases with more than 5 percent of blasts in bone marrow and as relapse to the central nervous system with the presence of blasts in cerebrospinal fluid

Progression free survival

时间窗: through study completion, an average of 1 year

Complete Remission

时间窗: through study completion, an average of 1 year

Bone marrow has less than 5 percent blast cells, blood cell counts are within the normal range, and there are no signs or symptoms of leukemia

COVID-19 confirmed

时间窗: From the date of leukemia diagnosis to the end of the induction chemotherapy cycle 1 (each cycle is 28 days)

Reactive SARS-CoV-2 RT-PCR test

次要结局

未报告次要终点

研究者

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

Christian Omar Ramos-Peñafiel, MD, PhD

Head of the hematology hospitalization area

Hospital General de Mexico

研究点 (2)

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