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临床试验/NCT02835911
NCT02835911进行中(未招募)不适用

LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi

UNC Lineberger Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 1,140 人开始时间: 2013年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,140
试验地点
2
主要终点
Number of patients with suspected lymphoma

研究概览

简要总结

This registry study is intended to establish a large prospective longitudinal clinical cohort of lymphoma patients in Malawi, as such data is currently lacking from sub-Saharan Africa. The investigators will perform core biopsies on at least 800 consecutively enrolled patients with suspected lymphoma for accurate histopathologic characterization. The investigators will systematically collect relevant clinical and laboratory data, and longitudinally follow those with confirmed hematologic malignancies receiving treatment according to local standards of care to assess outcomes.

详细描述

This is an observational cohort registry study of at least 800 patients with suspected lymphoma in Malawi. The primary purpose of this study is to develop a large prospective longitudinal lymphoma cohort at Kamuzu Central Hospital (KCH). Subjects with confirmed hematologic malignancies treated according to local standards of care will be actively followed for 2 years after diagnosis to assess clinical outcomes. After 2 years, if subjects are well, they will be discharged from clinic if they desire and contacted via telephone every 6 months for 5 years after lymphoma diagnosis simply to assess vital status. Subjects who wish to continue clinic follow-up after 2 years will be seen every 6 months until 5 years after lymphoma diagnosis. Those who are unwell after 2 years and continuing to receive active treatment will continue follow-up in clinic with all treatment details recorded.

All study laboratories and procedures which are being performed are consistent with international standards of care. Even without study implementation, all procedures may be undergone by patients at KCH, and there is no 'new' intervention being provided by the study which is currently absent in Malawi. However, current clinical and laboratory assessments of lymphoma patients at KCH over time are typically highly inconsistent and incomplete by international standards, as a result of extreme scarcity of resources and personnel. It is therefore hoped that the study will provide greater standardization and uniformity in the longitudinal characterization of patients with lymphoma at KCH, and allow data collected to be used for clinical as well as research purposes, as such data from sub-Saharan Africa are lacking and can be tremendously informative.

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
0 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Criteria: Inclusion Criteria:
  • Referred to Kamuzu Central Hospital (KCH) with clinically suspected lymphoma based on clinical impression of referring providers Age >5 years, or ≤5 years only if lymphoma has already been pathologically confirmed.
  • No prior or concurrent histologically confirmed cancer diagnosis or receipt of cancer treatment.
  • Residence <200 kilometers from KCH. Able to understand and comply with study procedures for the entire length of the study, with assistance of parent or guardian as applicable.
  • Subject (or parent or guardian as applicable) able to understand and provide written consent in English or Chichewa.
  • Informed consent reviewed and signed by patient, or for pediatric patients, from parent or guardian.

排除标准

  • There are no exclusion criteria other than failure to meet inclusion criteria listed above.
  • Patients may consent to participation in the study but refuse directed genomic analysis of their lymphoma specimens.

研究组 & 干预措施

Lymphoma

Suspected lymphoma with confirmed hematologic malignancies treated under local conditions

结局指标

主要结局

Number of patients with suspected lymphoma

时间窗: 5 years

At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.

次要结局

  • Number of patients with Epstein-Barr virus (EBV)(5 years)
  • Information collected on Clinical & HR Quality of Life Questionnaire(5 years)
  • Number of B-Cell Lymphomas(5 years)
  • Number of Non-Hodgkin lymphoma (NHL)(5 years)
  • Number of patients with Kaposi's sarcoma-associated herpesvirus (KSHV)(5 years)
  • Number of patients with childhood Burkitt lymphoma (BL)(5 years)
  • Number of patients with Non- Malignant disorders(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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