Clinical trial NCT02835911: Clinical Cohort of Lymphoma Patients in Malawi
Official title: LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Hematologic Malignancies
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Fogarty International Center of the National Institute of Health
First posted: 2016-07-18
Enrollment: 800
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 800 patients with suspected lymphoma in Malawi.

Brief summary: 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.

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.

Primary outcomes:
measure: Number of patients with suspected lymphoma
timeFrame: 5 years
Secondary outcomes:
measure: Number of patients with Epstein-Barr virus (EBV)
timeFrame: 5 years
measure: Information collected on Clinical & HR Quality of Life Questionnaire
timeFrame: 5 years
measure: Number of patients with Kaposi's sarcoma-associated herpesvirus (KSHV)
timeFrame: 5 years
measure: Number of B-Cell Lymphomas
timeFrame: 5 years
measure: Number of patients with childhood Burkitt lymphoma (BL)
timeFrame: 5 years
measure: Number of Non-Hodgkin lymphoma (NHL)
timeFrame: 5 years
measure: Number of patients with Non- Malignant disorders
timeFrame: 5 years
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: UNC Project
Study officials:
affiliation: UNC-CH
name: Satish Gopal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.