Grants Awarded

Date of Award
December 2017

Amount of Award
$50,000 ($10,000 per year for 5 years)

Layperson Summary

The LCH-IV Treatment Protocol Study (LCH-IVTPS) is an ambitious research clinical trial aiming to address unsolved clinical issues of primary importance for the patients (e.g. treatment of patients failing established standard treatment; treatment of patients with disease relapse; treatment of LCH of the brain). Therefore, besides evaluating the effectiveness of standard front-line treatment methods, the LCH-IV Study incorporates multiple treatment alternatives in addition to the front-line treatment. This approach of combining multiple treatment modalities and research objectives in one protocol adds significant complexity to the study design. Few studies in medical research have used this approach, making its introduction an important milestone in the field of histiocytosis research. Now physicians and hospitals from twenty countries from four continents are enrolling patients into this project. Collecting information of treatment success, drug side effects and patient outcomes would be impossible without remote data entry systems.

The Histiocyte Society Clinical Trials Database System (HSCTDS) is an online, remote data entry system built under the supervision of the Histiocyte Society. The costs for its development have been fully covered by a Grant of the Histiocytosis Association.

While the HSCTDS is currently used to collect information for the LCH-IV Treatment Protocol Study (LCH-IVTPS) only, it has the capacity to host all current and future Histiocyte Society Clinical Trials upon addition of respective modules. The system allows participants (physicians placing a patient or patients in the study) from around the world to conduct direct entry of patient information, whereas previous studies have required that data to be sent to a central location responsible for data entry. This new entry method decreases the time necessary to complete the lengthy paperwork associated with clinical trial questionnaires.

In order to facilitate effective data collection and patient enrollment, the HSCTDS incorporates innovative technology that includes mandatory data field completion and an automatic, patient follow-up notification system that alerts participants of the need to provide a subsequent data report. The increased efficiency of the HSCTDS will expedite the completion of the hosted studies, and result in the prompt publication and distribution of its findings. Financial support is needed to cover the yearly maintenance costs of the HSCTDS.