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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020856
Receipt No. 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

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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
Obsterics 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
Email 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
Email antira@faculty.chbia-u.jp

Sponsor
Institute Ciba University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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