UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020856 |
|---|---|
| Receipt number | R000024069 |
| Scientific Title | Exploratory study on the anti-proliferative effects of metformin on endometrial cancer |
| Date of disclosure of the study information | 2016/02/04 |
| Last modified on | 2020/02/06 09:42:40 |
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Basic information
Public title
Exploratory study on the anti-proliferative effects of metformin on endometrial cancer
Acronym
Exploratory study on the anti-proliferative effects of metformin on endometrial cancer
Scientific Title
Exploratory study on the anti-proliferative effects of metformin on endometrial cancer
Scientific Title:Acronym
Exploratory study on the anti-proliferative effects of metformin on endometrial cancer
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Anti-proliferative effect of metformin on endometrial cancer tissues have been observed in patients with endometrial cancer. However, it is unclear how metformin affects endometrial cancer in vivo. The aim of this study is to evaluate the effect of metformin on H19 non-cording RNA expression, DNA methylation, and the activity of aromatase in endometrial cancer tissue and to investigate the anti-proliferative effects of metformin in patients with endometrial cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the effect of metformin on H19 expression in endometrial cancer tissue
Key secondary outcomes
1. To evaluate the effect of metformin on DNA methylation in endometrial cancer tissue
2. To evaluate the effect of metformin on the activity of aromatase, expression of let7, c-myc Hmga2, lmp in endometrial cancer tissue
3. To evaluate the effect of metformin on the expression of biomarkers in the endometrium.
1) Differences in Ki67 and Topoisomerase IIa expression using immunohistochemistry.
2) Expression of PhosphorERK, PhosphorAKT, phosphor AMPK, phosphor-rpS6, cyclin D1 using western blot analysis
4. Evaluation of toxicity
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
| Medicine |
Interventions/Control_1
1)Patients will receive a daily dose of metformin (initial dose, 500 mg/day; increased weekly up to 2250 mg/day in the absence of any adverse effects).
2)Metformin will be administered in patients who fulfill the eligibility criteria. Metfomin will be administrated in patients until a day prior to the operation.
3)Endometrial biopsy samples will be obtained before metformin administration (as baseline) and during operation.
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically confirmed grade 1-2 endometrioid adenocarcinoma
2. BMI over 25 and positive for insulin resistance
3.Over 20 years and under 60 years of age
4.Eastern Cooperative Oncology Group Performance status 0
5.Patient who are ready to provide written informed consent
Key exclusion criteria
1. Prior medical history of chemical sensitivity to metformin
2. Serum creatinine over1.0 mg/dl
3. History of lactic acidosis
4. Patients undergoing dialysis
5. Shock, cardiac arrest, cardiac infarction, thrombosis of the lung, or severe cardiovascular and/or lung damage
6. Ingestion of excessive amounts of alcohol
7. Elevated levels of AST(GOT), ALT(GPT) (over2 times upper limit of normal)
8. History of thrombosis
9. Mental illness that may require the administration of antipsychotics
10. Diabetes mellitus that requires medication
11. HbA1c over 8.0
12. Concomitant malignancies
13. Determined to be ineligible by the physician in charge for any other reason
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Mitsuhashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Reproductive Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
antira@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Mitsuhashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Reproductive Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
antira@faculty.chbia-u.jp
Sponsor or person
Institute
Ciba University
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for Promotion of Science.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional Review Board at Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
Tel
043-222-7171
hanaoka.hideki@faculty.chiba-u.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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 04 | 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
15
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
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024069
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