UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023957
Receipt number R000022146
Scientific Title An observational study of osteoporosis after gastrectomy in gastric cancer patients
Date of disclosure of the study information 2016/09/07
Last modified on 2016/09/06 18:23:10

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Basic information

Public title

An observational study of osteoporosis after gastrectomy in gastric cancer patients

Acronym

An observational study of osteoporosis after gastrectomy in gastric cancer patients

Scientific Title

An observational study of osteoporosis after gastrectomy in gastric cancer patients

Scientific Title:Acronym

An observational study of osteoporosis after gastrectomy in gastric cancer patients

Region

Japan


Condition

Condition

Gastric cancer patients who have undergone gastrectomy

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prevalence of osteoporosis in gastric cancer patients who have undergone gastrectomy

Basic objectives2

Others

Basic objectives -Others

To search factors connected to the prevalence of osteoporosis in gastric cancer patients who have undergone gastrectomy

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Bone mineral density

Key secondary outcomes

1)Age
2)Sex
3)BMI
4)Information of gastrectomy
1.Operative method
2.Pathological stage
3.Chemotherapy
4.Recurrence
5)Complications
6)Medicine
7)Blood test
1.TRACP-5b
2.Serum calcium
3.Serum phosphorus
4.Serum creatinine
5.Serum albumen
6.Hemoglobin


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)Gastric cancer patients who have undergone gastrectomy
2)Pathological diagnosis:adenocarcinoma
3)Operative method, Reconstruction:No object
4)Age:more than 20 years old
5)Gender:No object
6)Out patient or inpatient:Out patient
7)Agreement to sign an informed consent

Key exclusion criteria

1)Women are pregnant or able to get pregnant
2)Women are nursing
3)Patients have mortal complications;heart disease, liver or kidney trouble
4)Patients were considered to be inappropriate by the physician

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koeda Keisuke

Organization

Iwate Medical University School of Medicine

Division name

Department of Surgery

Zip code


Address

19-1, Uchimaru, Morioka, Iwate

TEL

019-651-5111

Email

keikoeda@iwate-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Segawa Takenori

Organization

Iwate Medical University School of Medicine

Division name

Department of Surgery

Zip code


Address

19-1, Uchimaru, Morioka, Iwate

TEL

019-651-5111

Homepage URL


Email

tsegawa@iwate-med.ac.jp


Sponsor or person

Institute

Department of Surgery, Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

wate Medical University School of Medicine

Organization

Division

Category of Funding Organization

Other

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

2016 Year 09 Month 07 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

Enrolling by invitation

Date of protocol fixation

2015 Year 10 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The aim of this study is to survey prevalence of osteoporosis in post-gastrectomy patients. And we assess age, sex, body weight loss, tumor staging, operation type, history of chemotherapy, and laboratory data, and analyzed relation of these factors to osteoporosis and BMD levels.


Management information

Registered date

2016 Year 09 Month 06 Day

Last modified on

2016 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022146


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name