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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036749
Receipt No. R000041394
Scientific Title Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies
Date of disclosure of the study information 2019/05/15
Last modified on 2019/05/15

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Basic information
Public title Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies
Acronym MONSTAR-SCREEN
Scientific Title Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies
Scientific Title:Acronym SCRUM-Japan MONSTAR-SCREEN
Region
Japan

Condition
Condition Advanced Solid Malignancies
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To analyze circulating tumor DNA (ctDNA) and feces of patients with advanced solid malignancies over time to profile and monitor cancer-related genomic alterations and the gut microbiome.
Basic objectives2 Others
Basic objectives -Others To characterize the relationship of these profiles to clinical pathology, the clinical course of the disease (e.g., treatment history, response rate, progression-free survival, time to treatment failure), and cancer-related genomic alterations in tumor tissue
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Profiles of ctDNA cancer-related genomic alterations and the gut microbiome
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Is at least 16 years of age at the time of consent.
2. Has a histopathologically confirmed solid malignancy.
3. Has unresectable lesions.
4. Has undergone or is scheduled to undergo a comprehensive genomic profile that uses tumor tissue.
5. Has personally given consent in writing to participate in this study.
6. Satisfies either i or ii below:
i. Has not undergone chemotherapy.
ii. Was found to have progressed in diagnostic imaging performed while receiving chemotherapy or assessed by the investigator of likely having clinical progressive disease and has not yet begun the subsequent chemotherapy.
7. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
8. Results of latest laboratory tests performed within 21 days of enrollment satisfy all of the following .
9. Has no serious comorbidities.
10. Has a remaining life expectancy of at least 12 weeks after the day of enrollment.
11. Intends to receive study treatment based on the results of genomic alteration analysis.
12. Meets the description of one of Cohorts A to D below:
Cohort A: Patients with certain solid malignancies who have not undergone chemotherapy
Patients who have not yet undergone initial chemotherapy for an advanced solid malignancy specified.
Cohort B: Patients with certain genomic alterations
Patients found to have a genomic alteration specified in Reference Material in comprehensive genomic profile, the GOZILA Study, or FoundationOne Liquid of the present study and are scheduled to undergo chemotherapy as their subsequent chemotherapy.
Cohort C: Patients scheduled to undergo treatment with an immune checkpoint inhibitor
Patients whose next scheduled treatment is an immune checkpoint inhibitor.
Cohort D: Patients scheduled to undergo treatment with certain molecular targeted drugs
Patients whose next scheduled treatment is chemotherapy with a molecular targeted drug able to cause clonal evolution.
Key exclusion criteria 1. Has previously undergone an autologous stem cell transplant or organ transplant.
2. Has a history of other malignancies.
3. If found by the investigator to be unsuited to participate in the study.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Yoshino
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba.
TEL 04-7133-111
Email tyoshino@east.ncc.go.jp

Public contact
Name of contact person
1st name Yoshiaki
Middle name
Last name Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-111
Homepage URL
Email yoshinak@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization SCRUM Japan
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 Hospital East
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel 04-7133-111
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
2019 Year 05 Month 15 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
2019 Year 03 Month 07 Day
Date of IRB
2019 Year 03 Month 14 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study Design: Observational study
Target population:the patients who meet the selection criteria until March 31 2021 from research permit date

Management information
Registered date
2019 Year 05 Month 15 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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