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
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
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
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
