1. What are pediatric liver tumors and what is the Japanese Study Group for Pediatric Liver Tumor?

Pediatric liver tumor is a rare malignant tumor which occurs in livers of children. Most are a kind of hepatoblastoma, which is a tumor specific to children but sometimes we find adult-type hepatocellular carcinoma. In Japan there are 30 to 40 cases yearly. Complete surgical excision was the only therapeutic procedure till the 1980s. In the 1990s, a combination of an antineoplastic drug and surgical excision created the potential for recovery from (formerly) inoperable tumors, and tumors with metastasis. Also, the recurrence rate after surgery decreased. However, because the number of cases in Japan each year is so low, treating this low generation frequency tumor independently in each facility did not show the long-term treatment results and its issues nationwide. Therefore, aiming to improve the treatment methods for pediatric liver tumor, in 1991, Japanese Study Group for Pediatric Liver Tumor (JPLT) was formed nationwide. Treatment in Japan shows similar results compared with the U.S. and European countries and especially in tumors discovered early, we obtain a more than 90% survival rate using only half the quantity of antineoplastic drugs used in the West.


2. What is the aim of Japanese Study Group for Pediatric Liver Tumor?

Japanese Study Group for Pediatric Liver Tumor (JPLT) has been trying to develop better treatments for pediatric liver tumors carry out necessary related research on the treatment at the same time. For early stage tumors which we can expect to cure, we consider trying to use as low as dosage of antineoplastic drugs as possible. For advanced tumors which are difficult to cure, we consider providing the latest treatments. In addition, since antineoplastic drugs have become more widely used, we have discovered that different tumors react differently to the different drugs, with respect to rates of recurrence and so forth. Research into pediatric liver tumors is remarkably behind compared with other childhood cancers throughout the world. The JPLT Study Group aims to develop more relevant treatments corresponding to tumor cell characteristics by analyzing treatment progress of individual tumors categorizing tumors, with respect to their various characteristics.JPLT is presently working closely with the SIOPEL group in Europe and the COG group in the United States, and examining the same treatment with an aim of pooling research to move towards more established and internationally accepted treatment plan.


3. What kind of treatment will we get with JPLT and how do we register to take part in the protocol?

Anyone can participate in the JPLT Study Group trial. Please consult with your doctor. Once you agree to participate, your treatment will start after we have determined the status of the tumor. The whole treatment plan may take several months. Before the start of treatment, you must register with the JPLT Registration Office (Hiroshima University Natural Science Center for Basic Research and Development) and with the JPLT Research Secretariat (Hiroshima University Natural Science Center for Basic Research and Development), and you will be assigned a code number to ensure anonymity. Although, data such as information about tumors, treatment progress, extent of side-effects and level of disability and relapse after the treatment are reported to the secretariat from each facility, personal information is strictly handled, and a code number system is used in all exchanges of information, to ensure privacy. At the secretariat, accumulated data is summarized and the effectiveness and problems resulting from treatment are analyzed. In addition, each facility may request the latest treatment results and the latest side-effects data from the JPLT Study Group Secretariat. Central pathological examination of resected tumors by the JPLT pathologist is also available upon request.


4. What benefits can we expect from the treatment?

One of the benefits of participation in the JPLT program is that the whole treatment plan is clearly determined and intelligible. In addition, diagnosis by study group pathologists is available and for tumors which are difficult to cure, through the consultants, the consultation and referral to special faculties are available for specialized treatments.

Participating in this treatment and research program, not only gives you access to valuable information, but there is a possibilityfor you to help provide children who suffer from the same disease as your child and their families with many benefits in the future.


5.Where will research results be published?

Research results may be made public at conference presentations and published in research journals and on medical data-bases but every care will be taken to hide the names of patients and families.


6. Who pays for the treatment?

Expenses required maintaining the organization of JPLT Study Group and the expense required for genetic analysis research are covered by membership fees paid by JPLT Study Group participating facilities and grants for public organization research, so, patients and families do not need to pay for it.


7．What do we commit to if we agree to take part?

Agreement to participate in the protocol is non-compulsory and based on free will. Refusal to take part in the protocol will result in no disadvantage to or discrimination against the patient.  Patients may withdraw from the program at any time. On withdrawal, all the collected samples will be disposed of along with all test results and chart histories will not be used for any further research purposes. However, if results based on the patient’s date have already been published at the time of withdrawal, we will be unable to retract or dispose of such data.

(This agreement is considered effective until the time the patient turns 16 years old. When the patients turn 16 years old, the patients themselves are required to sign new agreements. In this case, issue of whether or not to inform the patient of the nature of their disease may come up. Patients will be approached directly for consent, only after considerable discussions with family members, and after having properly established that the patient is able to fully understand the nature of him/her disease.)


8.How will you maintain confidentiality and store our personal information?

A code number is assigned to each patient, and used in all communications to ensure anonymity and confidentiality. Therefore, even at private meetings of the JPLT Study Group and even in future publication of the research results, individuals cannot be identified. Our personal information administration staffs guarantee your personal information will be handled responsibly and securely. When the research facilities of JPLT Study Group analyze samples and test results from the patients, only the code numbers are transferred from the registration office. Therefore, it is impossible for researchers to know the personal name of the patients or families and your privacy is guaranteed. Similarly, when the JPLT pathologist examines patients’ data, the same code number system is employed to conceal patients’ true identities.