Clinical Cohort of Lymphoma Patients in Malawi

January 16, 2024 updated by: UNC Lineberger Comprehensive Cancer Center

LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

800 patients with suspected lymphoma in Malawi.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Lymphoma
Suspected lymphoma with confirmed hematologic malignancies treated under local conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with suspected lymphoma
Time Frame: 5 years
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
Information collected on Clinical & HR Quality of Life Questionnaire
Time Frame: 5 years
Clinical & HRQOL assessment
5 years
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
5 years
Number of B-Cell Lymphomas
Time Frame: 5 years
Diagnostic lymph node biopsy
5 years
Number of patients with childhood Burkitt lymphoma (BL)
Time Frame: 5 years
enrolling children ≤5 years with already pathologically confirmed BL diagnoses
5 years
Number of Non-Hodgkin lymphoma (NHL)
Time Frame: 5 years
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health

Investigators

  • Principal Investigator: Satish Gopal, MD, UNC-CH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Estimated)

January 31, 2030

Study Completion (Estimated)

January 31, 2030

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimated)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 1229
  • K01TW009488 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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