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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018329
Receipt No. R000021188
Scientific Title The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.
Date of disclosure of the study information 2015/08/01
Last modified on 2015/08/19

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Basic information
Public title The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.
Acronym The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.
Scientific Title The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.
Scientific Title:Acronym The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.
Region
Japan

Condition
Condition Gynecologic malignancies
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine incidence and clinical characteristics of treatment-related leukemia after taxan and platinum based chemotherapy.
Basic objectives2 Others
Basic objectives -Others incidence
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of treatment-related leukemia after only taxan and platinum(Pt) based chemotherapy.
Key secondary outcomes Incidence of TRL according to the combination of Taxan and Pt.
Relationship of total dose of Taxan and the Pt and the incidence of TRL.
Duration from the last chemotherapy to the TRL.
Characteristics of chromosomal abnormality and karyo
-type of TRL.
Treatment and outcome of TRL.

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients with pathologically confirmed ovarian cancer, uterine body cancer, cervical cancer.
Patients provided taxan and Pt based chemotherapy from January, 2002 to December, 2006.
When taxan and Pt based chemotherapy was provided as neo adjuvant chemotherapy, it applies.
Patients without medical history of malignancies before taxan and Pt based chemotherapy.
Patients provided only taxan and Pt based chemotherapy.
Key exclusion criteria Patients with radiation therapy.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyomi Satoh
Organization University of Tsukuba , Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-1-1 Tennodai, Tsukuba Ibaraki, 305-8575, Japan
TEL 029-853-3073
Email toyomi-s@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Sakurai
Organization University of Tsukuba , Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-1-1 Tennodai, Tsukuba Ibaraki, 305-8575, Japan
TEL 029-853-3073
Homepage URL http://www.md.tsukuba.ac.jp/clinical-med/ob-gyn/
Email m-sakurai@md.tsukuba.ac.jp

Sponsor
Institute Gynecologic Oncology Trial and Investigation Consortium of North Kanto (GOTIC)
Institute
Department

Funding Source
Organization Gynecologic Oncology Trial and Investigation Consortium of North Kanto (GOTIC)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2015 Year 08 Month 01 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
2015 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A retrospective observational study

Name of primary sponsor
Gynecologic Oncology Trial and Investigation Consortium of North Kanto (GOTIC)

Key inclusion criteria
Patients with pathologically confirmed ovarian cancer, uterine body cancer, cervical cancer.
Patients provided taxan and Pt based chemotherapy from January, 2002 to December, 2006.
When taxan and Pt based chemotherapy was provided as neo adjuvant chemotherapy, it applies.
Patients without medical history of malignancies before taxan and Pt based chemotherapy.
Patients provided only taxan and Pt based chemotherapy.
Patients without radiation therapy.

Outcomes
Incidence of treatment-related leukemia after only taxan and platinum(Pt) based chemotherapy.
Incidence of TRL according to the combination of Taxan and Pt.
Relationship of total dose of Taxan and the Pt and the incidence of TRL.
Duration from the last chemotherapy to the TRL.
Characteristics of chromosomal abnormality and karyo
-type of TRL.
Treatment and outcome of TRL.

Management information
Registered date
2015 Year 07 Month 15 Day
Last modified on
2015 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021188

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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