UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007816
Receipt number R000009212
Scientific Title Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system
Date of disclosure of the study information 2012/05/01
Last modified on 2018/08/11 06:54:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system

Acronym

Clinical study on sentinel lymphnode in gynecologic malignancies

Scientific Title

Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system

Scientific Title:Acronym

Clinical study on sentinel lymphnode in gynecologic malignancies

Region

Japan


Condition

Condition

gynecologic malignancies (cervical cancer, endometrial cancer, and vulvar cancer)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the validity of sentinel lymph node detection system in the treatment of gynecologic malignancies

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Histopathologic diagnosis of dissected lymph nodes, positive rate of sentinel lymph nodes, and validity of dissection range

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

Prevention

Type of intervention

Maneuver

Interventions/Control_1

99mTc labeled phytic acid and patent-blue dye is injected around the lesion one day before surgery and just prior to operation, respectively. Intraoperatively, colored sentinel lymph nodes (SLN) are also identified with RI-detection device. Systematic lymphadenectomy is performed to confirm tumor metastasis in all lymph nodes including SLN by histological investigation.

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

cervical cancer stage Ia-IIb
vulvar cancer stage Ia-II
endometrial cancer stage Ia-II

Key exclusion criteria

Those who cannot be afforeded to standard therapy

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Mandai

Organization

Kyoto University Graduate School of Medicine

Division name

Gynecology and Obstetrics

Zip code


Address

54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto

TEL

0757513269

Email

babatsu@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsukasa Baba

Organization

Kyoto University Graduate School of Medicine

Division name

Gynecology and Obstetrics

Zip code


Address

54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto

TEL

0757513269

Homepage URL


Email

babatsu@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine

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



Other administrative information

Date of disclosure of the study information

2012 Year 05 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

2012 Year 04 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 05 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

2012 Year 04 Month 23 Day

Last modified on

2018 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009212


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name