UNC Project
Lilongwe, Malawi
Location status: Recruiting
NCT Number: NCT02835911
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.
Interested in participating?
Request Info0 year–99 year
All sexes
Observational
Lilongwe, Malawi
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Criteria: Inclusion Criteria:
Exclusion criteria
Time frame: 5 years
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
Time frame: 5 years
Core biopsy specimens will be tested for the presence of EBV and extra serum sample at enrollment, mid-treatment, treatment completion, and 6 months to allow EBV viral load
Time frame: 5 years
Clinical & HRQOL assessment
Time frame: 5 years
Core biopsy specimens will be tested for the presence of KSHV and extra serum sample at enrollment, mid-treatment, treatment completion, and 6 months to allow EBV viral load
Time frame: 5 years
Diagnostic lymph node biopsy
Time frame: 5 years
enrolling children ≤5 years with already pathologically confirmed BL diagnoses
Time frame: 5 years
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
Time frame: 5 years
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
UNC Lineberger Comprehensive Cancer Center
Other
LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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