UMIN-CTR Clinical Trial

Basic information
Public title	A biomarker study to analyze genomic variations in circulating-tumor DNA and circulating tumor cells in gastrointestinal cancers (Valor trial)
Acronym	A biomarker study to analyze ctDNA/CTC in gastrointestinal cancers (Valor trial)
Scientific Title	A biomarker study to analyze genomic variations in circulating-tumor DNA and circulating tumor cells in gastrointestinal cancers (Valor trial)
Scientific Title:Acronym	A biomarker study to analyze ctDNA/CTC in gastrointestinal cancers (Valor trial)
Region	Japan

Condition
Condition	Gastrointestinal cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Cardiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The primary aim is to evaluate genomic markers and concordance with ctDNA and CTC in patients with metastatic GI cancers. Then, this study approaches to assess which biomarkers can predict clinical outcome more accurately.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Concordance in genomic profiling between ctDNA and CTC
Key secondary outcomes	1. Association between genetic status in ctDNA and clinical outcomes 2. Association between genetic status in CTC and clinical outcome 3. Compare genetic change between ctDNA and CTC in mCRC patients with RAS wild-type tumors treated with anti-EGFR mAb.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients with histologically confirmed diagnosis of GI cancers (esophageal, gastric, pancreatic, colorectal cancers) (2) Patients who receive systemic chemotherapy in first- or second-lines / Patients with RAS wild-type mCRC treated with anti-EGFR antibody at any-lines (3) ECOG PS 0 or 1 (4) Patients agree with blood draw at several times for ctDNA and CTC analyses
Key exclusion criteria	(1) Patients who are regarded as inadequate for study enrollment by investigators. (2) Patients do not agree with use of samples
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Sunakawa
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL	044-977-8111
Email	y.suna0825@gmail.com

Public contact
Name of contact person	1st name Shinko Middle name Last name Hanaki
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL	044-977-8111
Homepage URL
Email	rinshoushuyougaku-004@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	St. Marianna University School of Medicine IRB
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
Tel	044-976-9518
Email	nota@marianna-u.ac.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 05 Month 08 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	2018 Year 12 Month 17 Day
Date of IRB	2019 Year 03 Month 25 Day
Anticipated trial start date	2019 Year 05 Month 08 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Registering

Management information
Registered date	2019 Year 05 Month 08 Day
Last modified on	2020 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041793