UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sentinel lymph node biopsy for early stage cervical cancer.
Title of the study (Brief title)	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	Toshihiro Higuchi
Organization	Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name	Department of Obstetrics and Gynecology
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	Natsuki Tsuji
Organization	Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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