UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018957
Receipt number R000021793
Scientific Title Prospective cohort study on bone mineral dencity changes in the Stage 1,2 gastric cancer patients after gastrectomy
Date of disclosure of the study information 2015/09/10
Last modified on 2023/09/15 10:44:56

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Basic information

Public title

Prospective cohort study on bone mineral dencity changes in the Stage 1,2 gastric cancer patients after gastrectomy

Acronym

Prospective cohort study on bone mineral density changes after gastrectomy (LOHAS study)

Scientific Title

Prospective cohort study on bone mineral dencity changes in the Stage 1,2 gastric cancer patients after gastrectomy

Scientific Title:Acronym

Prospective cohort study on bone mineral density changes after gastrectomy (LOHAS study)

Region

Japan


Condition

Condition

gastric cancer patients with pathological stage 1 and 2

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the bone mineral dencity changes prospectively, in the patients who had gastric resection

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the rate of the bone mineral dencity changes per year

Key secondary outcomes

the incidence rate of the new vertebral body fracture,the incidence rate of the fragility fracture,the incidence rate of osteoporosis,P1NP,sNTX,alkaline-phosphatase


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

40 years-old <=

Age-upper limit

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1. The gastric cancer patients with stage 1 or 2
2. Having a T-score over -2.5 measured by the DXA method within 4 weeks after the gastric resection
3. Patients shall not have medicaland treatment history of osteoporosis
4. Patients shall not have treatment history of Androgen receptor antagonists,Aromatase inhibitor,Insulin,corticosteroid or vitamin D
5. Patients shall not have treatment history of chemotherapy,radiation therapy or any gastric resection
6. Performance Status(ECOG) 0 or 1
7. Written informed consent will be obtained from all patients

Key exclusion criteria

1.Hyperthyroidism,Hypothyroidism
2.Hyperparathyroidism,Hypoparathyroidism
3.Hypocalcemia,Hypercalcemia
4.Rheumatoid arthritis
5.Paget's disease of bone
6.Hyperprolactinemia
7.Chronic liver disease and Cirrhosis
8.Alcoholism
9.Chronic kidney disease and Renal insufficiency
10.Primary amenorrhea,Early menopause and the patients who have history of Oophorectomy before menopause
11.Patients determined to be inappropriate for this study

Target sample size

220


Research contact person

Name of lead principal investigator

1st name Motohiro
Middle name
Last name Imano

Organization

Kinki University Faculty of Medicine

Division name

Department of surgery

Zip code

589-8511

Address

377-2 onohigashi, osaka-sayama city, osaka, Japan

TEL

072-366-0221

Email

imano@med.kindai.ac.jp


Public contact

Name of contact person

1st name Motohiro
Middle name
Last name Imano

Organization

Kinki University Faculty of Medicine

Division name

Department of surgery

Zip code

589-8511

Address

377-2 onohigashi, osaka-sayama city, osaka, Japan

TEL

072-366-0221

Homepage URL


Email

imano@med.kindai.ac.jp


Sponsor or person

Institute

Japanese Gastirc cancer association

Institute

Department

Personal name



Funding Source

Organization

none

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

Kindai University

Address

ohnohigashi osakasayama osaka japan

Tel

+81-72-366-0221

Email

imano@med.kindai.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

日本胃癌学会関連組織


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 10 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

Completed

Date of protocol fixation

2015 Year 04 Month 14 Day

Date of IRB

2014 Year 09 Month 10 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study Design: Prospective cohort study

Recruitment: April 2015 to March 2018
Patients registered facility of gastric cancer Society were admitted, and conform to the selection criteria and obtained written informed consent.
Measurable item: bone density change rate, a new vertebral fracture incidence, a new fragility fracture incidence, osteoporosis etc.


Management information

Registered date

2015 Year 09 Month 09 Day

Last modified on

2023 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name