UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018377
Receipt number R000021277
Scientific Title Selective Sentinel Lymph Node Dissection and a One-step Nucleic Acid Amplification Assay for the Identification of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer
Date of disclosure of the study information 2015/07/22
Last modified on 2017/07/04 16:12:16

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Basic information

Public title

Selective Sentinel Lymph Node Dissection and a One-step Nucleic Acid Amplification Assay for the Identification of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer

Acronym

Sentinel OSNA assay of the lateral pelvic region

Scientific Title

Selective Sentinel Lymph Node Dissection and a One-step Nucleic Acid Amplification Assay for the Identification of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer

Scientific Title:Acronym

Sentinel OSNA assay of the lateral pelvic region

Region

Japan


Condition

Condition

Rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the feasibility of sentinel node metastases of lateral pelvic region in locally advanced rectal cancer using the one-step nucleic acid amplification assay.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Accuracy of sentinel node metastases

Key secondary outcomes

1)Sensitivity
2)Specificity
3)Positive Predictive Value(PPV)
4)Negative Predictive Value(NPV)
5)Detection rate
6)Adverse event rate


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

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

After Total Mesorectal excision(TME) for primary lesion, lateral pelvic node dissection was performed and picked up lymph nodes around inferior vesical artery as sentinel basin which were examined using the one-step nucleic acid amplification assay.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven as adenocarcinomas
2) clinical stage II or III
3) 1) Tumor located below the peritoneum.
4) Aged between 20 and 80 years old
5) ECOG Performance status of 0 or 1
6) no severe comobidity or organ disorder
7) willing to provide written informed consent

Key exclusion criteria

1) History of severe drug hypersensitivity
2) history of another malignancy within 5 years
3) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure.
4) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy
5) Physician concludes that the patient's participation in this trial is inappropriate

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuyoshi Ota

Organization

Yokohama City University Medical Center

Division name

Gastroenterological surgery

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

m_ota@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuyoshi Ota

Organization

Yokohama City University Medical Center

Division name

Gastroenerological Center

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japa

TEL

045-261-5656

Homepage URL


Email

m_ota@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

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

2015 Year 07 Month 22 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

No longer recruiting

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 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

2015 Year 07 Month 22 Day

Last modified on

2017 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021277


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name