UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014530
Receipt number R000008355
Scientific Title Search of a new tumor marker and examination of usefulness by multi-institutinal study
Date of disclosure of the study information 2014/07/11
Last modified on 2021/07/06 11:49:26

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Basic information

Public title

Search of a new tumor marker and examination of usefulness by multi-institutinal study

Acronym

Search of a new tumor marker and examination of usefulness by multi-institutinal study

Scientific Title

Search of a new tumor marker and examination of usefulness by multi-institutinal study

Scientific Title:Acronym

Search of a new tumor marker and examination of usefulness by multi-institutinal study

Region

Japan


Condition

Condition

Breast cancer, Thyroid cancer, Esophageal cancer, Gastric cancer, Colon cancer, Liver cancer, Biliary cancer, Pancreatic cancer

Classification by specialty

Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the usefulness of novel tumor markers of the patients with various solid tumors using blood samples before and after surgical treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tumor markers to be analyzed are as follows. Positive rate of each tumor marker. Analysis of correlation with clinicopathological factors and various blood concentration.

-New tumor markers(cancer-specific protein and IgG antibody cancer antigen-specific antibody such as SEREX)
-Existing tumor markers(p53 antibody, CEA, SCC-Ag, CYFRA21-1, AFP, CA19-9, CA125, midkine, TPA, and IAP)

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

Prevention

Type of intervention

Other

Interventions/Control_1

Save and analysis the sampling blood collected using a tube of 5 ml for biochemistry blood collection at the same time at the time of visit as an outpatient or admission from patients who obtained consent to this study.

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)Cases that were suspected or was diagnosed as malignant tumors clinicaly.
(2)Patients who have been informed of the diagnosis as a result of malignancy.
(3)Age to 20 years of age or older
(4)Having a sufficient judgment capability.

Key exclusion criteria

(1)Patients who are judged inappropriate for this study by the investigator

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Hideaki
Middle name
Last name Shimada

Organization

Toho University, School of Medicine

Division name

Department of Surgery

Zip code

143-8541

Address

6-11-1, Omorinishi Ota-ku, Tokyo, 143-8541 Japan

TEL

03-3762-4151

Email

hideaki.shimada@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Shimada

Organization

Toho University School of Medicine

Division name

Department of Surgery

Zip code

143-8541

Address

6-11-1 Omori-nishi Ota-ku Tokyo 143-8541 Japan

TEL

03-3762-4151

Homepage URL


Email

hideaki.shimada@med.toho-u.ac.jp


Sponsor or person

Institute

Toho Univerisity

Institute

Department

Personal name



Funding Source

Organization

Toho University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Toho University

Address

6-11-1 Omori-nishi Otaku Tokyo Japan

Tel

03-3762-4151

Email

hideaki.shimada@med.toho-u.ac.jp


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

2014 Year 07 Month 11 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Open public recruiting

Date of protocol fixation

2011 Year 07 Month 11 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 07 Month 10 Day

Last modified on

2021 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008355


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name