Clinical Cohort of Lymphoma Patients in Malawi

Lymphoma Clinical Trial

Official title:

LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02835911
• Other study ID #: LCCC 1229
• Secondary ID: K01TW009488
• Status: Recruiting
• Start date: November 2012
• Est. completion date: January 31, 2030

Study information

• Verified date: January 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 31, 2030
• Est. primary completion date: January 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Lymphoma

Locations

Country	Name	City	State
Malawi	UNC Project	Lilongwe

Sponsors (3)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with suspected lymphoma	At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.	5 years
Secondary	Number of patients with Epstein-Barr virus (EBV)	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
Secondary	Information collected on Clinical & HR Quality of Life Questionnaire	Clinical & HRQOL assessment	5 years
Secondary	Number of patients with Kaposi's sarcoma-associated herpesvirus (KSHV)	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
Secondary	Number of B-Cell Lymphomas	Diagnostic lymph node biopsy	5 years
Secondary	Number of patients with childhood Burkitt lymphoma (BL)	enrolling children =5 years with already pathologically confirmed BL diagnoses	5 years
Secondary	Number of Non-Hodgkin lymphoma (NHL)	At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.	5 years
Secondary	Number of patients with Non- Malignant disorders	At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.	5 years

External Links

•   UNC Lineberger Comprehensive Cancer Center