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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001356
Receipt No. R000001650
Scientific Title Proteome and metaborome analyses for drug response in cancer patients with solid tumor receiving chemotherapy
Date of disclosure of the study information 2008/09/04
Last modified on 2014/03/04

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Basic information
Public title Proteome and metaborome analyses for drug response in cancer patients with solid tumor receiving chemotherapy
Acronym Proteome and metaborome analyses in drug response for cancer chemotherapy
Scientific Title Proteome and metaborome analyses for drug response in cancer patients with solid tumor receiving chemotherapy
Scientific Title:Acronym Proteome and metaborome analyses in drug response for cancer chemotherapy
Region
Japan

Condition
Condition Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We perform proteome and metaborome analyses in cancer patients with solid tumor receiving chemotherapy. We also analyze pharmacokinetics and pharmacodynamics for the cancer chemotherapy. We analyze whether or not these are useful biomarker(s) to predict efficacy and toxicity of cancer chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Genetic polymorphisms in factors associated with pharmacokinetics and pharmacodynamics of anticancer drugs, proteome and metaborome, anticancer effects and adverse drug reactions.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 genome, pharmacokinetics, proteome and metaborome
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with histologically confirmed solid tumors.
2)Patients who are 20 years or higher.
3)Patients with ECOG performance status of 0 to 3.
4)Patients who are expected to live at least 2 months or more.
5)Patients with measurable and evaluable lesion(s).
6)Patients never treated with the target anticancer drug(s). No history of chemotherapy or within 3 weeks.
7)Blood tests
1. Neutrophile count 2000 /mm3 or higher.
2. Platelet count 100,000 /mm3 or higher.
3. Hemoglobin 9.0 g/dL or higher.
4. AST, ALT less than 2.0 times the upper limit of normal.
5. Total bilirubin 2.0 mg/dL or less.
6. Serum creatinine 1.5 mg/dLor less.
8)All patients were asked for written informed consent for their
peripheral blood samples and medical information to be used for
research purposes.
Key exclusion 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.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasutsuna Sasaki
Organization Saitama Medical University, International Medical Center
Division name Medical Oncology
Zip code
Address 1397-1, Yamane, Hidaka city, Saitama
TEL 042-984-4679
Email ysasaki@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasutsuna Sasaki
Organization Saitama Medical University, International Medical Center
Division name Medical Oncology
Zip code
Address 1397-1, Yamane, Hidaka city, Saitama
TEL 042-984-4679
Homepage URL
Email ysasaki@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University, International Medical Center,
Department of Medical Oncology
Institute
Department

Funding Source
Organization Saitama Medical University, International Medical Center,
Department of Medical Oncology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Showa University, School of Medicine, Division of Respiratory and Allergy Department of Internal Medicine
Keio University, School of Medicine, Department of Pharmacy
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 09 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2008 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2011 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 09 Month 04 Day
Last modified on
2014 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001650

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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