UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002485 |
|---|---|
| Receipt number | 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 14:19:17 |
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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
| Obstetrics 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
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
yyoshida@u-fukui.ac.jp
Sponsor or person
Institute
Office of the ethically screening committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003041
