Challenge Fund Grant (2015)
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Program: Clinical Studies
Coordinators: Melissa Adde
Other INCTR Participants: Ian Magrath, Lorenzo Leoncini
Collaborators: Valeria Colbi, Emma Seaford, Nick Seaford, Muheez Durosinmi, Roberto Ferrara
Branch(es): INCTR (Brussels) and INCTR Challenge Fund
Location: Single Country
Country(s): Uganda, Tanzania, Nigeria
Institutions: Lacor Hospital, Gulu, Uganda, Mwanza Hospital, Owoluw-
Background Information: The Burkitt Lymphoma Project has been in existence since 2004, although during this period, some hospitals have participated for periods of a few years only.
Objectives: Improve the Diagnosis and Therapy for African Burkitt lymphoma in children and adults
Methods: INCTR Staff and External Collaborators spend varying periods of time in the participating centers providing suggestions and advice regarding the program and the existing ifrastructure.

Funding is obtained from various sources: In the early years, NCI, Bethesda, subsequently, then the Nisbet Foundation, The Opec Fund for International Development, Global Giving and INCTR membership fees.
Progress: In April, 2015, the International Network for Cancer Treatment and Research (INCTR), Brussels submitted a request for funding to the Challenge Fund in the amount of £17,028.50 (approximately $26,000 based upon rates of exchange at that time). The funding was intended to cover the costs of the drugs for the treatment of Burkitt lymphoma (BL), but also for supportive care medications (i.e., antibiotics, anti-fungals and analgesics) for three centres participating in the study at that time. INCTR was the recipient of a grant from the OPEC Fund for International Development (OFID) which was nearing its completion in terms of funding. One centre, the Obafemi Awolowo Teaching Hospitals Complex (OAUTHC) in Nigeria was unable to benefit from the grant due to Nigeria being an OPEC country which made it ineligible to receive OFID funds. Therefore, funds to support the costs of drugs in addition to the salary of study data manager were requested. Funds from the Challenge Fund were also requested to cover the costs of the purchase of monoclonal antibodies for immunohistochemistry (IHC) for two centres, The Bugando Medical Centre (BMC) in Mwanza, Tanzania and St Mary’s Hospital Lacor (LH) in Gulu, Uganda, although the amounts requested were insufficient to cover the costs of the agents required. OFID agreed to allow INCTR to purchase the reagents and equipment for LH. INCTR had intended to provide the same to BMC, but upon a monitoring visit made by a pathologist, it was learned that there was no equipment, staff or pathologist trained to do IHC. Therefore, it was considered more worthwhile to utilize available funding (OFID and Challenge Fund) to purchase the reagents and equipment for LH. INCTR, in turn, provided funds to the Challenge Fund from the OFID grant to cover costs associated with cancer registration at both BMC and LH. This totaled some $12,050.
Funds from the Challenge Fund were transferred to INCTR in July, 2015. The total amount of the funds transferred was £18,000 or some €25,151. INCTR provides funds to the recipients in USD. Therefore, INCTR reports its expenditures of funds from the Challenge Fund in USD.
Centre Item Requested Funds USD Expenditure (USD) BMC Drugs 7,000.00 7,335.00
Reagents (IHC) 2,000.00 0.00
LH Drugs 11,000.00 13,000.00
Reagents (IHC) 2,000.00 4,000.00
OAUTHC Drugs 2,500.00 2,500.00
Data Manager Salary, Home Visits, Admin fees 1,500.00 1,897.00
TOTAL 26,000.00 28,732.00

Note: INCTR had requested £17,000 and received £18,000. Any excess in expenditures from Challenge Fund funding provided was covered by INCTR.

Progress During 2015

Among all three centres, a total of 81 patients were enrolled on the study during 2015 (39, LH; 35, BMC; 7, OAUTHC). Data remains largely entered at LH, but is incomplete in terms of response or outcome data. In late 2015, Dr. Valeria Calbi who ran the BL protocol at LH decided that she would return to Italy. Therefore, attempts were made to train a new data manager and a new clinician in the treatment of BL according to the protocol prior to her departure. Unfortunately due to lengthy vacations of staff around the time of her departure, she was largely unable to oversee the completion of the data entry. While there is an experienced pediatrician there, it is clear through communications that data management is behind – even in completing the data for patients enrolled in 2015. In early 2016, the BMC underwent a data monitoring visit. As this centre had failed a monitoring visit in 2014, it was agreed that patient accrual would resume at such time when a trained team – including a data manager, research nurse and clinician – was appointed. This was accomplished in 2015 and patient accrual resumed. At the time of the 2016 monitoring visit, it was determined that data entered into the study database could not be verified for accuracy. The research nurse died and the clinician assigned to treat the patients was leaving for specialist training. At that time, it was agreed that INCTR would no longer fund BMC until such time as a trained team was in place and that the Principal Investigator (PI) was able to properly supervise the staff assigned to the BL protocol. A visiting pathologist from Italy recommended that the BMC invest in the equipment, reagents and personnel necessary to conduct IHC in order to ensure long-term sustainability. He managed to obtain the agreement of the African company that provides the reagents and equipment for IHC to train BMC personnel free of charge. Although the Institutional Director at BMC agreed to this, there has been no progress on this in 2016. Provisionally, INCTR support will resume in 2017, but only for the treatment protocol (i.e, staff support and funds for the drugs). Data is incomplete for OAUTHC. Their data manager is new, but was trained by the previous data manager prior to his departure. Because the PI is actively engaged as are his team, he has been notified about the data entry deficiencies and asked to rectify these problems as soon as possible.
Given the changes at the two centres, it seemed premature to initiate the new treatment protocol as intended in 2016.
However, in 2015, many other accomplishments on the ground were achieved under the broader scope of the project, “Developing a Model of Care for the Treatment of Burkitt Lymphoma in Africa” (largely supported by OFID). The objectives included the establishment of hospital networks, the initiation of public and professional education directed towards minimizing delays in reaching an often distant tertiary care center capable of providing therapy for this disease, continuing to improve the quality of diagnosis and treatment provided by the tertiary care centers and to identify potential approaches to ensuring the sustainability of the overall program. These objectives were largely accomplished, but all of them are in their earliest and most vulnerable stages. True sustainability will require the training of additional staff, the solidification of relationships between the tertiary care centers and several NGO’s concerned with supporting cancer patients (e.g., by providing transportation or arranging for accommodation and food for the patient and parent while treatment is ongoing). A cancer registry has been established at LH, but case finding, although increasing, still covers only half of the catchment area. Since the registry covers all cancers, additional diagnostic accuracy, based on the application of more specific methods is required to ensure the validity of the data regarding incidence and mortality. Training of the cancer registrar at BMC was undertaken and visits made to assess the quality of data.
At present the responsibility for patient care and documentation of results rests on the shoulders of a precariously small, though competent team, such that data collection related to the BL study can and does fall behind as a result of absence of the single data manager. Similarly, treatment would have to be continued by less experienced staff in the event of the unavailability of the project coordinator. Community awareness has improved such that it appears that the rate of referral is increasing – another reason for the need for training of additional specialist staff, but requires frequent repetition to ensure that the messages conveyed are not forgotten because of lack of sufficient repetition. Finally, more information needs to be collected about the reasons for delays – both to permit the development of more effective approaches to overcome them, but also to create a more scientific atmosphere relating to this and other projects. A survey of this kind was introduced at LH, but needs to be expanded
Future Plans: To continue to improve all aspects of the treatment of African Burkitt Lymphoma including:
Public Education regarding the signs of the disease and importance of rapid diagnosis and treatment. Achieve improvements in survival rate by modifying therapy. The most immediate need is improved diagnosis
Duration: Continuing project
Publications:
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Year: 2015
Last Update: 12/2015
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