UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017209 |
|---|---|
| Receipt number | R000019966 |
| Scientific Title | Prospective cohort study of abdominal radical trachelectomy (RAT) for the early stage invasive uterine cervical cancer |
| Date of disclosure of the study information | 2015/04/21 |
| Last modified on | 2015/04/21 15:08:06 |
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Basic information
Public title
Prospective cohort study of abdominal radical trachelectomy (RAT) for the early stage invasive uterine cervical cancer
Acronym
RAT for the cervical cancer
Scientific Title
Prospective cohort study of abdominal radical trachelectomy (RAT) for the early stage invasive uterine cervical cancer
Scientific Title:Acronym
RAT for the cervical cancer
Region
| Japan |
Condition
Condition
uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Since firstly reported as a procedure of fertility-sparing surgery in 1994, radical trachelectomy has been widely accepted for standard treatment modality for patients with early stage cervical cancer. National Comprehensive Cancer Network Guidelines version 1.2014 recommended to perform radical trachelectomy with pelvic lymph node dissection +/- para-aortic lymph node sampling when patients wish fertility preservation and have stage IA 2 and IB1, tumor diameter < 2 cm, and squamous histology. However, treatment outcomes of radical trachelectomy including laparoscopic approach for Japanese patients with early stage cervical cancer have been reported only by retrospective studies at single institution. Therefore, to evaluate surgical, prognostic and pregnancy outcomes of radical abdominal trachelectomy (RAT), we conducted prospective cohort study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
surgical outcomes
recurrence rates
pregnancy outcomes
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
abdominal 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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically confirmed cervical cancer
2) FIGO stage IA2 to IB1
3) Squamous cell carcinoma
4) Tumors less than 2cm in size determined by preoperative magnetic resonance imaging
5) Patients desired fertility-sparing surgery
6) Patient's age:20-40 years.
Key exclusion criteria
lymph node metastasis was revealed by intaraoperative diagnosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Niikura |
Organization
Tohoku University Hospital
Division name
Department of gynecology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7254
niikura@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Tokunaga |
Organization
Tohoku University Hospital
Division name
Department of gynecology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7254
Homepage URL
tokunagahideki@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2002 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 08 | 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
| 2015 | Year | 04 | Month | 21 | Day |
Last modified on
| 2015 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019966
