Clinical Cohort of Lymphoma Patients in Malawi
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|ClinicalTrials.gov Identifier: NCT02835911|
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : August 13, 2019
|Condition or disease|
|Lymphoma Hematologic Malignancies|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Suspected lymphoma with confirmed hematologic malignancies treated under local conditions
- Number of patients with suspected lymphoma [ Time Frame: 5 years ]At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
- Number of patients with Epstein-Barr virus (EBV) [ 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
- Information collected on Clinical & HR Quality of Life Questionnaire [ Time Frame: 5 years ]Clinical & HRQOL assessment
- Number of patients with Kaposi's sarcoma-associated herpesvirus (KSHV) [ 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
- Number of B-Cell Lymphomas [ Time Frame: 5 years ]Diagnostic lymph node biopsy
- Number of patients with childhood Burkitt lymphoma (BL) [ Time Frame: 5 years ]enrolling children ≤5 years with already pathologically confirmed BL diagnoses
- Number of Non-Hodgkin lymphoma (NHL) [ Time Frame: 5 years ]At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
- Number of patients with Non- Malignant disorders [ Time Frame: 5 years ]At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835911
|Contact: Satish Gopal, MD 265-1-755-056 firstname.lastname@example.org|
|Principal Investigator:||Satish Gopal, MD||UNC-CH|