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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002485
Receipt No. R000003041
Scientific Title The usefulness of the abdominal radical trachelectomy and pelvic lymphadenectomy for the women who disiered of the pregnancy in early-stage cervical cancer
Date of disclosure of the study information 2009/10/01
Last modified on 2009/09/13

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Basic information
Public title The usefulness of the abdominal radical trachelectomy and pelvic lymphadenectomy for the women who disiered of the pregnancy in early-stage cervical cancer
Acronym The usefulness of the abdominal radical trachelectomy and pelvic lymphadenectomy
Scientific Title The usefulness of the abdominal radical trachelectomy and pelvic lymphadenectomy for the women who disiered of the pregnancy in early-stage cervical cancer
Scientific Title:Acronym The usefulness of the abdominal radical trachelectomy and pelvic lymphadenectomy
Region
Japan

Condition
Condition Women with early cervical cancer who wish to retain fertility.
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In gynecologic oncology surgery, partial organ resection with radical abdominal or vaginal trachelectomy and pelvic lymph node dissection are relatively new techniques utilized in women with early cervical cancer who wish to retain fertility. The purpose of this study is to evaluate our technique of radical abdominal trachelectomy, a fertility-sparing operation in women with cervical cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pathologic parameters will be gathered from the final pathology report. Tumor diameter will be estimated clinically when a visible lesion was noted or from final pathology based on the longest dimension of the lesion. At our institution, all patients will be followed up for the outcomes.
Key secondary outcomes the rate of pregnancy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 that patients younger than 40 years of age with operable stage I cervical cancer may be eligible for fertility-sparing radical trachelectomy
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
16 years-old <
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria 1. A desire for future fertility.

2. A proven diagnosis of cervical cancer.

3. Squamous cell carcinoma, early adenocarcinoma

4. Tumor size less than 2 cm.

5. Stage IA1 disease with lymph vascular space invasion, stage IA2 disease, or stage IB1 disease.

6. Tumor limited to the cervix as confirmed by preoperative pelvic magnetic resonance imaging (MRI).

7. No evidence of pelvic lymph node metastases.

8. No previous documentation of infertility.
Key exclusion criteria we do not exclude patients on the basis of other factors
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Yoshida
Organization University of Fukui,Facultory of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address Matuoka ,Eiheiji-Cho, Yoshida-Gun, Fukui-ken
TEL 81-776-61-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Yoshida
Organization University of Fukui,Facultory of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address Matuoka ,Eiheiji-Cho, Yoshida-Gun, Fukui-ken
TEL 0776-61-3111
Homepage URL
Email yyoshida@u-fukui.ac.jp

Sponsor
Institute Office of the ethically screening committee
Institute
Department

Funding Source
Organization University of Fukui, Facultory of Medicine,Department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JJapan

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 福井大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2009 Year 10 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 Preinitiation
Date of protocol fixation
2009 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2018 Year 03 Month 01 Day
Date of closure to data entry
2019 Year 03 Month 01 Day
Date trial data considered complete
2019 Year 03 Month 01 Day
Date analysis concluded
2020 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 13 Day
Last modified on
2009 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003041

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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