UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021415 |
|---|---|
| Receipt number | R000024704 |
| Scientific Title | Clinical study to detect sentinel lymph nodes for personalized treatment for cervical cancer |
| Date of disclosure of the study information | 2016/03/11 |
| Last modified on | 2019/03/15 22:01:33 |
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Basic information
Public title
Clinical study to detect sentinel lymph nodes for personalized treatment for cervical cancer
Acronym
Clinical study on sentinel lymph nodes in cervical cancer
Scientific Title
Clinical study to detect sentinel lymph nodes for personalized treatment for cervical cancer
Scientific Title:Acronym
Clinical study on sentinel lymph nodes in cervical cancer
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To calculate the detecting rate, sensitivity and false negative rate in sentinel node navigation surgery (SNNS) for cervical cancer and to determine the validity of less-invasive surgery using SNNS with the aim of clinical application of SNNS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number and the location of sentinel lymph node, the sensitivity and specificity of sentinel node navigation surgery for cervical cancer
Key secondary outcomes
1 Evaluation of the safety of SNNS
2 Diagnostic accuracy of touch smear of sentinel lymph nodes
3 Analysis of host immune environment in sentinel lymph nodes
4 Evaluation of diagnostic accuracy of setinel lymph nodes based on diagnostic imaging
5 Detection of the sentinel lymph nodes based on anatomy
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
We perform the standard surgery including systematic retroperitoneal lymph nodes dissection along with detecting sentinel lymph nodes in cervical cancer patients.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1 Pathologically-diagnosed cervical cancer patients with no obvious metastasis who are scheduled to receive operation
2 Patients of twenty and over who yield written concent
Key exclusion criteria
1 Patients suspicious of positive lymph node metastasis on pre-operative diagnostic imaging
2 Patients with other malignancies
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoko Tanaka |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
35 shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211-62386
kkyokokeio@a5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Tanaka |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
35 shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211-62386
Homepage URL
kkyokokeio@a5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine, Department of Obstetrics and Gynecology
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
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024704
