UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001356 |
|---|---|
| Receipt number | 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 09:49:05 |
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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
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
ysasaki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University, International Medical Center,
Department of Medical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001650
