Clinical Cohort of Lymphoma Patients in Malawi
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lymphoma, Hematologic Malignancies. Basic parameters: 0 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malawi
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi
Overview
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.
Detailed description
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.
Primary outcome measures
- Number of patients with suspected lymphoma [Time frame: 5 years]
Secondary outcome measures (7)
- Number of patients with Epstein-Barr virus (EBV) [Time frame: 5 years]
- Information collected on Clinical & HR Quality of Life Questionnaire [Time frame: 5 years]
- Number of patients with Kaposi's sarcoma-associated herpesvirus (KSHV) [Time frame: 5 years]
- Number of B-Cell Lymphomas [Time frame: 5 years]
- Number of patients with childhood Burkitt lymphoma (BL) [Time frame: 5 years]
- Number of Non-Hodgkin lymphoma (NHL) [Time frame: 5 years]
- Number of patients with Non- Malignant disorders [Time frame: 5 years]
Eligibility criteria
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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Malawi · 1 center
- UNC Project — Lilongwe
Publications
- Gondwe Y, Kudowa E, Tomoka T, Kasonkanji ED, Kaimila B, Zuze T, Mumba N, Kimani S, Mulenga M, Chimzimu F, Kampani C, Randall C, Lilly A, Gopal S, Fedoriw Y, Painschab M. Comparison of baseline lymphoma and HIV characteristics in Malawi before and after implementation of universal antiretroviral therapy. PLoS One. 2022 Sep 1;17(9):e0273408. doi: 10.1371/journal.pone.0273408. eCollection 2022. PMID 36048901
- Kaimila B, van der Gronde T, Stanley C, Kasonkanji E, Chikasema M, Tewete B, Fox P, Gopal S. Salvage chemotherapy for adults with relapsed or refractory lymphoma in Malawi. Infect Agent Cancer. 2017 Aug 9;12:45. doi: 10.1186/s13027-017-0156-3. eCollection 2017. PMID 28808480
Identifiers
NCT: NCT02835911 · LCCC 1229 · K01TW009488