UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006508
Receipt number R000007722
Scientific Title A clinical study of intraoperative diagnosis of sentinel lymph node metastasis in head and neck cancer patients using bimolecular methods
Date of disclosure of the study information 2011/10/12
Last modified on 2012/04/10 08:12:46

* 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

A clinical study of intraoperative diagnosis of sentinel lymph node metastasis in head and neck cancer patients using bimolecular methods

Acronym

Intraoperative diagnosis of lymph node metastasis in head and neck cancer patients using one-step nucleic acid amplification

Scientific Title

A clinical study of intraoperative diagnosis of sentinel lymph node metastasis in head and neck cancer patients using bimolecular methods

Scientific Title:Acronym

Intraoperative diagnosis of lymph node metastasis in head and neck cancer patients using one-step nucleic acid amplification

Region

Japan


Condition

Condition

Oral cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to develop a more efficient method for intraoperative detection of lymph node metastasis in head and neck cancer patients using bimolecular methods.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

We evaluate the concordance rate between the OSNA assay and histopathology for lymph node metastases.

Key secondary outcomes

Cutoff values to distinguish macrometastasis, micrometastasis, and nonmetastasis are determined by measuring cytokeratin 19 (CK19) mRNA in histopathologically positive and negative lymph nodes using OSNA.


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

Device,equipment

Interventions/Control_1

We evaluate the lymph node metastasis in head and neck cancer patients using bimolecular methods.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Previously untreated head and neck squamous cell carcinoma patients who surgical resection are indicated as a primary treatment, are the candidates for our study.

Key exclusion criteria

1)Previously treated patients
2)Patients judged by the investigator to be unfit to be enrolled into the study

Target sample size

21


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhisa Hasegawa

Organization

Aichi Cancer Center

Division name

Department of Head and Neck Surgery

Zip code


Address

1-1 Kanokoden Chikusaku, Nagoya 464-8681, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuhisa Hasegawa

Organization

Aichi Cancer Center

Division name

Department of Head and Neck Surgery

Zip code


Address

1-1 Kanokoden Chikusaku, Nagoya 464-8681, Japan

TEL

052-762-6111

Homepage URL


Email

hasegawa@aichi-cc.jp


Sponsor or person

Institute

Aichi Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Health and Labor Sciences Research Grant for Clinical Cancer Research (H21-Gannorinshou-Ippan-016)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

1)Fukushima Medical University
2)Kyorin University
3)Gunma University

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

2011 Year 10 Month 12 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

Completed

Date of protocol fixation

2008 Year 10 Month 29 Day

Date of IRB


Anticipated trial start date

2008 Year 12 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 10 Month 09 Day

Last modified on

2012 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007722


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name