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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029282
Receipt No. 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

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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
Obsterics 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
Email 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
Email n-tsuzi@kitano-hp.or.jp

Sponsor
Institute Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033470

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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