Projects｜j-CCRC Japan Consortium of Clinical Research Core Hospitals

Research subjectInstitutionArea of the studyDevelopment itemsRegulatory approval

Innovative Hair TestingOsaka University HospitalOther than cancerOtherUnapproved

Study
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Safety and Immunogenicity of the Malaria Vaccine Candidate BK-SE36/CpG in Healthy Malaria-Exposed African Adults and Children Living in Burkina FasoOsaka University HospitalOther than cancerDrugsUnapproved

Study
outline
The malaria vaccine candidate BK-SE36 is based on a recombinant form of the Plasmodium falciparum serine repeat antigen (SERA). The safety and immunogenicity of BK-SE36 was demonstrated in a phase Ia trial in malaria naive Japanese adults; and in a phase Ib trial conducted in healthy subjects aged 6-32 years from a malaria endemic area in Northern Uganda.The trial promising results justified the conduct of a phase Ib trial of BK-SE36 in younger cohorts aged from 1 - 5 years old toddlers in Burkina Faso. This on-going trial aims at testing the immune response in younger cohorts that has so far not been included in BK-SE36 malaria vaccine clinical trial, compare clinical trial results from two African countries with different malaria endemicity and generate additional data on safety, immunogenicity and possible preliminary efficacy of BK-SE36.The immune response to BK-SE36 may still be improved with the use of DNA sequences containing CpG motifs that can selectively promote cellular and/or humoral immune responses. A phase Ia clinical trial using BK-SE36/CpG was conducted in healthy adults in Japan where the vaccine was deemed safe and elicited antibody titres were 3- to 4- fold higher as compared to BK-SE36 alone. The proposed clinical trial will assess BK-SE36/CpG safety and immunogenicity in a population exposed to malaria.
A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare cancers in ASIANational Cancer Center HospitalCancer---Others

Study
outline
The study collect advanced-stage rare cancer patients’ data including biological information, treatment, and prognosis in the Asia-Pacific region and analyze the incidence of gene alteration, prognosis, and the treatment efficacy.
Asian multicenter prospective study of circulating tumor DNA sequencing: A-TRAINNational Cancer Center HospitalCancer---Others

Study
outline
To perform next-generation sequencing (NGS) of cell free-DNA (cfDNA) in blood samples from Asian cancer patients, and to analyze the types and incidences of genetic abnormalities in this population.
限局性⽪質形成異常の脳MRI所⾒と治療予後の関連Juntendo University HospitalOther than cancer---Off-label use

Study
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SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed Metastatic Prostate CancerJuntendo University HospitalCancerOtherOthers

Study
outline
This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.
PROtective ventilation with high versus low PEEP during one-lung ventilation for THORacic surgery PROTHOR: A randomized controlled trialJuntendo University HospitalOther than cancerMedical devices---

Study
outline
One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP).

Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV.

Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.
ベトナム⼈糖尿病患者の⾎糖コントロールとヘルスリテラシーの関連に関する研究Juntendo University HospitalOther than cancer------

Study
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Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib +/- Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast CancerNational Cancer Center HospitalCancerDrugsOff-label use

Study
outline
To demonstrate the superiority of palbociclib in combination with tamoxifen (with or without goserelin) over tamoxifen (with or without goserelin) alone in prolonging investigator assessed progression-free survival (PFS) in women with hormone receptor (HR) positive/HER2 negative advanced or metastatic breast cancer, regardless of their menopausal status.
A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel AdenocarcinomaNational Cancer Center HospitalCancerDrugsOff-label use

Study
outline
To confirm the superiority in terms of relapse-free survival (RFS) of post-operative CAPOX therapy to observation for curative resected pathological stage I/II/III small bowel adenocarcinoma.

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