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Recommendations for the Treatment of Children With Burkitt's Lymphoma (GFALMB2019)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04425421
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
French Africa Pediatric Oncology Group

Study Description
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Brief Summary:
This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.

Condition or disease Intervention/treatment
Burkitt Lymphoma Other: OBSERVATIONAL

Detailed Description:
This is the 4th Burkitt's Lymphoma (LMB) study by the GFAOP group. This study hopes to include at least 14 Sub Saharian countries some of whom have never participated in a LMB study. The evaluation of improvement in early diagnosis should be possible in this study. The study hopes to be able to evaluate children earlier, with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for children with a stage IV disease.
Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Recommendations for the Treatment of Children With Burkitt's Lymphoma
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Intervention Details:
  • Other: OBSERVATIONAL
    OBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE

Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the number of cases with local disease. [ Time Frame: 5 years ]
    evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage.

  2. Evaluation of the number of cases by stage at the time of diagnosis. [ Time Frame: 5 Years ]
    evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.

  3. Evaluating the treatment given. [ Time Frame: 5 Years ]
    Comparison of treatment given and recommended treatment.

  4. Evaluating the follow up after treatment. [ Time Frame: 5 Years ]
    How many children alive or dead after treatment

  5. Number of relapse cases [ Time Frame: 5 years ]
    The evaluation and the treatment of relapse and outcome


Secondary Outcome Measures :
  1. Application of therapeutic recommendations [ Time Frame: 5 years ]
    Evaluations of the correct application of recommendations


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All Children with a Burkitt's Lymhoma.
Criteria

Inclusion Criteria:

Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.

-

Exclusion Criteria:

Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.

Contacts and Locations
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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): NCT04425421


Contacts
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Contact: Chantal Ms BOUDA, Dr. 00(226)70 10 01 30 cgbouda@yahoo.fr
Contact: BRENDA MALLON, MSc 0033142115411 brenda.mallon@gustaveroussy.fr

Locations
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Côte D'Ivoire
CHU de Treichville à ABIDJAN
Abidjan, Côte D'Ivoire
Sponsors and Collaborators
French Africa Pediatric Oncology Group
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: French Africa Pediatric Oncology Group
ClinicalTrials.gov Identifier: NCT04425421    
Other Study ID Numbers: GFA LMB 2019
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin