UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029282 |
|---|---|
| Receipt number | R000033470 |
| Scientific Title | Sentinel lymph node biopsy for early stage cervical cancer. |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2017/10/12 16:22:46 |
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Basic information
Public title
Sentinel lymph node biopsy for early stage cervical cancer.
Acronym
Sentinel lymph node biopsy for early stage cervical cancer.
Scientific Title
Sentinel lymph node biopsy for early stage cervical cancer.
Scientific Title:Acronym
Sentinel lymph node biopsy for early stage cervical cancer.
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility and prognosis of sentinel lymph node biopsy for stage 1a2-2 cervical cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
over all survival
Key secondary outcomes
5 year survival
progression free survival
detection rate of sentinel lymph node
negative predictive value
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
1. Cervical injection of 99m Tc - phytate (55-70MBq) on 3-6-9-12 o`clock position.
2. Lymphoscintigraphy (15:00 the day before surgery)
3. Lymphoscintigraphy (8:00 the operation day)
4. Cervical injection of 1% patent blue (each 1ml) or ICG (each 1ml) on 3-6-9-12 oclock position.
5. SNL detection with RI probe (Navigator ) and blue dye or ICG.
6. Intraoperative pathologic daiagnosis.
7. Pelvic lymphadenectomy
SLN metastasis(+), not detecting SLN: systemic lymphadenectomy
SLN metastasis(-): SLN biopsy
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
| 85 | years-old | > |
Gender
Female
Key inclusion criteria
Early stage (1A2-2) cervical cancer
Squamous cell carcinoma, adenocarcinoma
ECOG Performance Status,0-1
Key exclusion criteria
Patient with pelvic lymeph node metastasis on imaging.
Pataients with severe complications.
The patients who are unappropriate for this study judged by the physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Higuchi |
Organization
Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN,530-8480
TEL
06-6312-1221
ts-higuchi@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuki Tsuji |
Organization
Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN,530-8480
TEL
06-6312-1221
Homepage URL
n-tsuzi@kitano-hp.or.jp
Sponsor or person
Institute
Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
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
田附興風会医学研究所 北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | 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
| 2017 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033470
