UMIN-CTR Clinical Trial

Basic information
Public title	Validation of an Integrated Somatic and Epigenomic Circulating Tumor DNA Assay using Blood Samples from Patients with Resectable Locally Advanced Rectal Cancer
Acronym	COSMOS-VOLTAGE
Scientific Title	Validation of an Integrated Somatic and Epigenomic Circulating Tumor DNA Assay using Blood Samples from Patients with Resectable Locally Advanced Rectal Cancer
Scientific Title:Acronym	COSMOS-VOLTAGE
Region	Japan

Condition
Condition	Resectable Locally Advanced Rectal Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate ctDNA LUNAR assay for patients who will start preoperative chemoradiotherapy intending to enroll the VOLTAGE study
Basic objectives2	Others
Basic objectives -Others	To evaluate the correlation between microbiome and the efficacies of the VOLTAGE study in patients who will start preoperative chemoradiotherapy intending to enroll the VOLTAGE study
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Positive rate of LUNAR assay
Key secondary outcomes	Correlation between post-operative positive rate of LUNAR assay and prognosis Correlation between status of LUNAR assay and efficacies of VOLTAGE treatment Concordance of gene status between LUNAR assay and tumor tissue Concordance of MSI status between LUNAR assay and tumor tissue Correlation between microbiome and the efficacies of the VOLTAGE study

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with resectable LARC who will participate in VOLTAGE cohort D 2. Agree to receive preoperative chemoradiation 3. Age of >= 20 to < 80 years at time of informed consent 4. Willing to provide blood samples per protocol. 5. Has given written consent
Key exclusion criteria	1. Pregnant. 2. Judged by the study doctor to be ineligible for the study for any other reason.
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Yoshiaki Middle name Last name Nakamura
Organization	Naitonal Cancer Center Hospital East
Division name	Department of Gastroenterology and Gastrointestinal Oncology
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL	04-7133-1111
Email	yoshinak@east.ncc.go.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Bando
Organization	Aichi Cancer Center
Division name	Department of Clinical Oncology
Zip code	464-8681
Address	1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL	052-764-6111
Homepage URL
Email	hbando@aichi-cc.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	National Cancer Center Hospital East
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Cancer Center Institutional Review Board
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel	04-7133-1111
Email	irst@ml.res.ncc.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	2020 Year 04 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	Preinitiation
Date of protocol fixation	2020 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2022 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 04 Month 14 Day
Last modified on	2020 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045780