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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004852
Receipt No. R000005770
Scientific Title The exploratory study for the biological effects of metformin on endometrial cancer: effect to cell cycle, MAPK, and AMPK/mTOR signal pathway
Date of disclosure of the study information 2011/01/11
Last modified on 2012/10/24

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Basic information
Public title The exploratory study for the biological effects of metformin on endometrial cancer: effect to cell cycle, MAPK, and AMPK/mTOR signal pathway
Acronym The exploratory study for the effects of metformin on endometrial cancer
Scientific Title The exploratory study for the biological effects of metformin on endometrial cancer: effect to cell cycle, MAPK, and AMPK/mTOR signal pathway
Scientific Title:Acronym The exploratory study for the effects of metformin on endometrial cancer
Region
Japan

Condition
Condition endometrial carcinoma
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It is unclear whether therapeutic doses of metformin are effective for patients with endometrial cancer.
To confirm direct and indirect effect of metformin for patients with endometrial cancer.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes To evaluate the effects of metformin, cell proliferation activity and signal pathway were compared between pre- and post-treatment samples.
1) Cell proliferation was evaluated by immunohistochemistry using antibody of Ki-67 (positive for all cell cycle except for G0) and topoisomerase II A(positive at S/G2/M phase)
2) Findings related to the MAPK, AMPK and mTOR signaling pathways and cell cycle proteins were compared by Western blot analysis.
Key secondary outcomes To evaluate the effect for endocrine factors ( HOMA-R, insulin, glucose, leptin, adiponectin)

To evaluate the antiproliferative effect of patients serum obtained before and after treatment

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Metformin (an initial dose of 750 mg/day, increased by 750 mg every week up to 1500 or 2250 mg/day) was administered to patients with endometrial cancer prior to surgery.
Endometrial tissue was obtained before and during metformin therapy via endometrial biopsy for diagnosis and hysterectomy, respectively. Patients undergo blood sample collection periodically for biomarker analysis.
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
70 years-old >
Gender Female
Key inclusion criteria (1) Histrogically confirmed grade 1-2 endometrioid adenocarcinoma
(2) myometrium invasion was ruled out by MRI
(3)performance status of 0
(4) serum creatinine <0.8mg/dl
(5) A case without hypersensitivity for this treatment use medicine
(6) The case that written informed consent was obtained before participation
Key exclusion criteria (1) The case with a history of the hypersensitivity that is serious for this study use medicine or the drug allergy
(2)A history of the lactic acidosis
(3)Patients on dialysis
(4)Shock, failure heart, myocardial infarction, a cardiovascular injury including the pulmonary embolism
(5)Excessive alcohol intake
(6)Hepatic dysfunction
(7) A history of the thrombosis
(8)A case with the psychic disturbance that it seems that we need in the treatment or treatment with antimental medicine
(9) Patients with diabetes
(10)A case with the double cancer of the activity
(11)In addition, the case that the chief physician judged to be inadequate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name akira mitsuhahsi
Organization Graduate School of Medicine, Chiba University
Division name Reproductive Medicine
Zip code
Address 1-8-1 inohana chuoku chiba japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name akira mitsuhashi
Organization Graduate School of Medicine, Chiba University
Division name Reproductive Medicine
Zip code
Address
TEL 043-226-2121
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 01 Month 11 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
2010 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 10 Day
Last modified on
2012 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005770

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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