Proteome and metaborome analyses for drug response in cancer patients with solid tumor receiving chemotherapy

UMIN ID: UMIN000001356

Registered date:04/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Cancer
• Date of first enrollment: 2008/09/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): genome, pharmacokinetics, proteome and metaborome

Outcome(s)

• Primary Outcome: Genetic polymorphisms in factors associated with pharmacokinetics and pharmacodynamics of anticancer drugs, proteome and metaborome, anticancer effects and adverse drug reactions.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients with interstitial pneumonia or pulmonary fibrosis. 2)Patients with severe infection (with fever). 3)Patients with incontrollable diabetes. 4)Patients with severe heart failure. 5)Patients with severe complication such as cirrhosis. 6)Patients with mental or nerve disorder. 7)Pregnant patients or patients giving the breast. Men and wemen who want to make baby. 8)Patients with severe allergy or those who had severe allergy in the past. 9)Patients who are contraindication for cancer chamotherapy. 10)Patients hypersensitive to the anticancer drug(s). 11)Patients who are not appropriate to participate in the study safely.

Related Information

• Primary Sponsor: Saitama Medical University, International Medical Center, Department of Medical Oncology
• Secondary Sponsor: Showa University, School of Medicine, Division of Respiratory and Allergy Department of Internal Medicine Keio University, School of Medicine, Department of Pharmacy
• Source(s) of Monetary Support: Saitama Medical University, International Medical Center, Department of Medical Oncology