NCT02835911

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,140

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Apr 2013Jun 2031

Study Start

First participant enrolled

April 30, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

18.2 years

First QC Date

January 19, 2016

Last Update Submit

September 9, 2026

Conditions

LymphomaHematologic Malignancies

Outcome Measures

Primary Outcomes (1)

  • Number of patients with suspected lymphoma

    At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.

    5 years

Secondary Outcomes (7)

  • Number of patients with Epstein-Barr virus (EBV)

    5 years

  • Information collected on Clinical & HR Quality of Life Questionnaire

    5 years

  • Number of patients with Kaposi's sarcoma-associated herpesvirus (KSHV)

    5 years

  • Number of B-Cell Lymphomas

    5 years

  • Number of patients with childhood Burkitt lymphoma (BL)

    5 years

  • +2 more secondary outcomes

Study Arms (1)

Lymphoma

Suspected lymphoma with confirmed hematologic malignancies treated under local conditions

Eligibility Criteria

Age0 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

800 patients with suspected lymphoma in Malawi.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients may consent to participation in the study but refuse directed genomic analysis of their lymphoma specimens.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Project

Lilongwe, Malawi

Location

Related Publications (2)

  • 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: 36048901DERIVED

  • 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: 28808480DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Left-over blood and tissue to be stored for future research testing.

MeSH Terms

Conditions

LymphomaHematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteHematologic Diseases

Study Officials

  • Yuri Fedoriw, MD

    UNC-CH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

July 18, 2016

Study Start

April 30, 2013

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2031

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)