UMIN-CTR Clinical Trial

Basic information
Public title	A Study of the Probability and Course of Jaw Corruption by Drugs: Observations in Patients with Lung Cancer and Bone Metastases in Multiple Facilities
Acronym	RING-ML01
Scientific Title	Incidence and treatment outcomes of medication-related osteonecrosis of the jaw: A prospective observational multicenter study of patients with primary lung cancer and bone metastases
Scientific Title:Acronym	RING-ML01
Region	Japan

Condition
Condition	medication-related osteonecrosis of the Jaw
Classification by specialty	Pneumology Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Occurrence rate of MRONJ in patients with primary lung cancer and bone metastases
Basic objectives2	Others
Basic objectives -Others	Identify the risk factors of MRONJ
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence rate of MRONJ in patients with primary lung cancer and bone metastases
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	120 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients with primary lung cancer (2) Patients scheduled to receive BMA for bone metastases (3) Patients who understand the contents of the study and are capable of providing written informed consent
Key exclusion criteria	(1) Patients with a history of BMA use for bone metastases (2) Patients with past or present osteomyelitis or osteonecrosis of the jaw (3) Patients with jawbone lesions such as jawbone metastases (4) Patients with a history of receiving radiation therapy in the jawbone (5) Patients who have developed head and neck cancer or have a history of it (6) Patients judged to be inappropriate by the principal investigator or subinvestigator
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kazuya Middle name Last name Yoshida
Organization	National Hospital Organization Kyoto Medical Center
Division name	oral and maxillofacial surgery
Zip code	612-8555
Address	1-1 Mukaihata-cho Fukakusa Fushimi-ku, Kyoto, Japan
TEL	075-641-9161
Email	yoshida.kazuya.ut@mail.hosp.go.jp

Public contact
Name of contact person	1st name maiko Middle name Last name shimosato
Organization	National Hospital Organization Kyoto Medical Center
Division name	oral and maxillofacial surgery
Zip code	612-8555
Address	1-1 Mukaihata-cho Fukakusa Fushimi-ku, Kyoto, Japan
TEL	075-641-9161
Homepage URL
Email	maikoshimosato0629@hotmail.co.jp

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Operating Expenses Grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Central Ethics Review Committee, National Hospital Organization
Address	5-5-21 2-chome,Higashigaoka Meguro-ku, Tokyo
Tel	03-5712-5050
Email	700-kenkyu@mail.hosp.go.jp

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	2019 Year 11 Month 14 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	Open public recruiting
Date of protocol fixation	2019 Year 10 Month 11 Day
Date of IRB	2019 Year 10 Month 11 Day
Anticipated trial start date	2019 Year 11 Month 18 Day
Last follow-up date	2024 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No Special Notes

Management information
Registered date	2019 Year 11 Month 14 Day
Last modified on	2019 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043729