UMIN-CTR Clinical Trial

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

Cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

09

Month

04

Day

URL releasing protocol

Publication of results

Published

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

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 related 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