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Clinical Cohort of Lymphoma Patients in Malawi

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ClinicalTrials.gov Identifier: NCT02835911
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease
Lymphoma Hematologic Malignancies

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: LCCC 1229: Developing a Prospective Lymphoma Clinical Cohort in Malawi
Study Start Date : November 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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



Primary Outcome Measures :
  1. Number of patients with suspected lymphoma [ Time Frame: 5 years ]
    At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.


Secondary Outcome Measures :
  1. 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

  2. Information collected on Clinical & HR Quality of Life Questionnaire [ Time Frame: 5 years ]
    Clinical & HRQOL assessment

  3. 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

  4. Number of B-Cell Lymphomas [ Time Frame: 5 years ]
    Diagnostic lymph node biopsy

  5. Number of patients with childhood Burkitt lymphoma (BL) [ Time Frame: 5 years ]
    enrolling children ≤5 years with already pathologically confirmed BL diagnoses

  6. Number of Non-Hodgkin lymphoma (NHL) [ Time Frame: 5 years ]
    At the time of initial assessment, all patients will undergo diagnostic lymph node biopsy.

  7. 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.


Biospecimen Retention:   Samples Without DNA
Left-over blood and tissue to be stored for future research testing.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
800 patients with suspected lymphoma in Malawi.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835911


Locations
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Malawi
UNC Project Recruiting
Lilongwe, Malawi
Contact: Satish Gopal, MD    265-1-755-056    gopal@med.unc.edu   
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Institutes of Health (NIH)
John E. Fogarty International Center (FIC)
Investigators
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Principal Investigator: Satish Gopal, MD UNC-CH

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02835911     History of Changes
Other Study ID Numbers: LCCC 1229
K01TW009488 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases