LymphomaNCT02835911
Clinical Cohort of Lymphoma Patients in Malawi
An observational study of Lymphoma and Hematologic Malignancies, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Malawi.
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. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Lymphoma, Hematologic Malignancies
- How many people
- 1,140 participants
- Where
- 1 siteMalawi
- Study dates
- 30 Apr 2013to 30 Jun 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 800 patients with suspected lymphoma in Malawi.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphoma, Hematologic Malignancies
- Medical subject headings
- Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lymphoma | Suspected lymphoma with confirmed hematologic malignancies treated under local conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with suspected lymphoma
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
Measured: 5 years
Secondary outcomes (7)
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
Measured: 5 years
Information collected on Clinical & HR Quality of Life Questionnaire
Clinical \& HRQOL assessment
Measured: 5 years
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
Measured: 5 years
Number of B-Cell Lymphomas
Diagnostic lymph node biopsy
Measured: 5 years
Number of patients with childhood Burkitt lymphoma (BL)
enrolling children ≤5 years with already pathologically confirmed BL diagnoses
Measured: 5 years
Number of Non-Hodgkin lymphoma (NHL)
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
Measured: 5 years
Number of patients with Non- Malignant disorders
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start30 Apr 2013
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,140 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Yuri Fedoriw, MD, Principal investigator, UNC-CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835911
- Sponsor's protocol ID
- LCCC 1229
- Other IDs
- K01TW009488
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2016
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 36048901Kaimila 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.
PubMed 28808480
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi
- ClinicalTrials.gov ID
- NCT02835911
- Acronym / sponsor ID
- LCCC 1229
- Conditions
- Lymphoma, Hematologic Malignancies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,140 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 30 Apr 2013 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoma | – | –Suspected lymphoma with confirmed hematologic malignancies treated under local conditions |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 800 patients with suspected lymphoma in Malawi.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with suspected lymphoma
Time frame: 5 years
At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 36048901Gondwe 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.
- Derived from this study: PubMed 28808480Kaimila 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.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingObservational study
Collection of Tissue Samples for Cancer Research
Neoplasms, Lymphomas
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Tissue Collection for Studies of Lymph Cancer
Hodgkin Disease, Lymphoma, Non-Hodgkin
Active, not recruitingPhase 2
Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuri Fedoriw, MD principal investigator
UNC-CH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Hematologic Malignancies, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with suspected lymphoma (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.