UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006442
Receipt number R000007637
Scientific Title Observational study of Serum HER2 in HER2 negative advanced gastric cancer treated with capecitabine plus cisplatin(XP)
Date of disclosure of the study information 2011/09/29
Last modified on 2017/10/06 13:05:02

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Basic information

Public title

Observational study of Serum HER2 in HER2 negative advanced gastric cancer treated with capecitabine plus cisplatin(XP)

Acronym

SHERLOCK2 Trial

Scientific Title

Observational study of Serum HER2 in HER2 negative advanced gastric cancer treated with capecitabine plus cisplatin(XP)

Scientific Title:Acronym

SHERLOCK2 Trial

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the changes of serum HER2 during the chemotherapy.
To evaluate the efficacy and safety of XP in the clinical practice for HER2 negative advanced gastric cancer.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of serum HER2

Key secondary outcomes

Progression Free Survival
Safety
Response rate
Overall survival
Receive rate of the 2nd line treatment
Complete rate of 2 cycle of XP
Relationship between serum HER2 and tissue HER2


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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) Histologically confirmed adenocarcinoma of the stomach
2) 20 years old or over
3) HER2 negative or unknown
4) Eligible for XP by the investigator's decision
5) Signed informed consent

Key exclusion criteria

1)Other malignancies within the last 2 years, except for carcinoma in situ or basal cell carcinoma.
2)Positive serum pregnancy test in women of childbearing, or lactating women.
3)History of psychiatric disability judged by investigator to be clinically significant, precluding informed consent.
4)Serious intercurrent infections.
5)Patients whom physician determines as inappropriate

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Arimura

Organization

Sapporo Medical University

Division name

1st department of Internal Medicine

Zip code


Address

S1, W16, Chuo-ku, Sapporo City

TEL

011-611-2111

Email

arimura@samed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mayuko Saito

Organization

Sapporo Medical University

Division name

1st department of Internal Medicine

Zip code


Address

S1, W16, Chuo-ku, Sapporo City

TEL

011-611-2111

Homepage URL


Email

m.saitou@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University 1st department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

Sapporo Medical University 1st department of Internal Medicine

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


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

2011 Year 09 Month 29 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

No longer recruiting

Date of protocol fixation

2011 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a observational study to investigate the changes of serum HER2 in HER2 negative advanced gastric cancer during the chemotherapy.


Management information

Registered date

2011 Year 09 Month 29 Day

Last modified on

2017 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007637


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name