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Clinical Research Studies

The types of research studies that INCTR’s Strategy Groups have undertaken or are underway include:

  • Information-Seeking
    The objectives of such studies are to determine reasons for delays in diagnosis and treatment through interviews of patients or parents of children with cancer.
  • Situational Analyses
    The objectives of situational analyses are to retrospectively profile specific cancers.
  • Treatment Protocols
    Treatment studies are designed to be feasible to conduct in the setting of low and middle income countries with varying resources.  The purpose of these studies is not to test new drugs, but to optimize treatment, to ensure that treatment is delivered in a standard fashion according to a protocol, and to collect accurate data about the effects of treatment, including patient outcomes.   Participation in clinical trials raises clinical standards, ensures greater discipline of the delivery of care, and ensures that greater efforts are made to follow patients in order to accurately measure outcome or to make new observations, such as factors that may influence survival. In addition to the immediate benefits to patients enrolled on these studies, treatment studies also have a broad range of beneficial effects on patient care outside of the context of the clinical trial - exploring diagnostic accuracy, drug availability and patient follow up – and instills accountability and reveals deficiencies that can be identified and addressed.

The Clinical Trials Office coordinates the activities of the Clinical Research Program, including the organization of INCTR Strategy Group meetings, the management of clinical research studies and the administration of INCTR's Ethical Review Committee. In addition, it provides education and training in the conduct of clinical research.

Current Clinical Research Studies

The Treatment and Characterization of Burkitt Lymphoma in Africa

African BL Strategy Group Meeting
BL Patients at Ocean Road Cancer Institute

Five institutions representing 4 sub-Saharan African countries are presently enrolling patients in this study.  These institutions are: Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria, University College Hospital, Ibadan, Nigeria, St. Mary’s Hospital, Lacor, Uganda, Kenyatta National Hospital, Nairobi, Kenya and the Ocean Road Cancer Institute in Dar Es Salaam, Tanzania.  Over 400 patients have been enrolled on the study.  

The protocol consists of a First-Line regimen for newly diagnosed, previously untreated patients and a Second-Line regimen for patients who fail to respond to the First-Line  regimen or who relapse early following the completion of treatment with First-Line therapy.

Results of the study have been presented at many international meetings; The International Conference on BL and Lymphoproliferative Disorders held in Kampala, Uganda in February, 2008, the International Conference on Malignant Lymphomas held in Lugano, Switzerland in June, 2008, the 41st Congress of the International Society of Pediatric Oncology held in São Paulo, Brazil in October, 2009 and at the African Organisation for Research and Training in Cancer 2009 Conference, in November, 2009.

Generous donations from the Christopher Niblett family and friends and from families of patients treated at Georgetown University in the USA have contributed to the purchase of the chemotherapy drugs for the patients on this study. The study is also supported by the Office of HIV/AIDS Malignancies of the NCI. 

A Retrospective Survey of Presentation Features of Breast Cancer and Risk Factors for Treatment Outcome

Institutions in Peru (Instituto Nacional des Enfermedades Neoplasicas), Egypt (NCI, Cairo), India (Cancer Institute, Chennai) and Pakistan (Jinnah Hospital) have contributed data for 8880 women with breast cancer treated between 1993 and 2001. Partial support for this study was obtained from the Komen for the Cure Foundation and from the Office of International Affairs, NCI.

The Treatment and Characterization of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults

This study is being conducted in four institutions in India – the All India Institute of Medical Sciences, New Delhi, the Cancer Institute, Chennai, the Tata Memorial Center, Mumbai and the Jaslok Hospital and Research Centre in Mumbai.  Patient enrollment began in 2004 and was completed in August, 2009.  A total of 473 patients were entered onto the study.  Partial support for this study was obtained from the Sir Ratan Tata Trust.

A Descriptive Study of Nasopharyngeal Carcinoma (NPC) in Low and Middle Income Countries

Institutions in 13 countries in Latin America, Africa and Asia have agreed to participate in a questionnaire study of adult patients and parents of children with NPC in order to learn more about the factors that may contribute to delays in diagnosis and treatment and to assess consanguinity and family history of NPC.  The study was approved by INCTR’s Ethical Review Committee in March 2010 and is presently undergoing local review and approval at participating institutions.

Understanding Problems Faced by Parents of Children with Retinoblastoma Prior to Treatment

Public Awareness Campaign for Retinoblastoma

Institutions from Brazil, Bolivia, Mexico, Guatemala, Nigeria, Tanzania, Zimbabwe, Turkey, India and Pakistan have participated in this study. A total of 435 parents have been interviewed. Results of the study have been presented at the 41st Congress of the International Society of Pediatric Oncology, held in São Paulo, Brazil in October, 2009.

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