UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043899
Receipt number R000050019
Scientific Title A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors
Date of disclosure of the study information 2021/04/12
Last modified on 2023/08/18 10:20:22

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Basic information

Public title

A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors

Acronym

SCRUM-Japan MONSTAR-SCREEN-2

Scientific Title

A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors

Scientific Title:Acronym

SCRUM-Japan MONSTAR-SCREEN-2

Region

Japan


Condition

Condition

Advanced Solid Malignancies

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Breast surgery Obstetrics and Gynecology Ophthalmology
Dermatology Oto-rhino-laryngology Urology
Oral surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To perform whole exome sequencing (WES), whole transcriptome sequencing (WTS), immunohistochemistry (IHC), etc. on tumor tissue in patients with advanced solid malignant tumors, and to perform WES, Sanger sequence, Multiplex Ligation-dependent Probe Amplification (MLPA), etc. on peripheral blood mononuclear cells, and elucidate molecular abnormalities in a multi-layered manner. By also performing WES/WTS on circulating tumor nucleic acid (ctNA) before and after drug therapy, the spatial-temporal heterogeneity will also be evaluated comprehensively, and also, by performing WES/WTS/IHC upon progression after drug therapy (including during systemic therapy and at the completion of planned treatment), the mechanism of treatment resistance will be evaluated. In addition, intestinal microbiota analysis using fecal specimens will be performed before and after drug therapy to evaluate the intestinal microbiota profile. Furthermore, by performing plasma proteomics before and after drug therapy on trace amounts of plasma proteins in the blood, we will also analyze dynamic changes in biological signals before and after treatment. Also, by using artificial intelligence (AI) and the like to analyze the relationship between that profile and clinical pathological factors, clinical course (treatment history, response rate, progression-free survival, duration of successful treatment, overall survival, etc.) and the like, biomarkers that reflect the biomolecular essence of solid malignant tumors will be created.

Basic objectives2

Others

Basic objectives -Others

This research is observational research to evaluate the profiles of genetic abnormalities, RNA expression, and biomarkers in tumor tissue and ctNA and the profiles of germline genetic abnormalities in blood evaluated with germline profile, gut microbiota profile, plasma protein profile and the results of protein expression in tumor tissue evaluated with tissue genome profiling and IHC, and the like, in terms of their relationship with clinical pathological factors, clinical course, etc.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

i. Profiles of gene abnormalities, RNA expression, biomarkers, protein expression, etc. in tumor tissue.
ii. Profiles of gene abnormalities, RNA expression, biomarkers, etc. in ctNA.
iii. Profile of germline gene abnormalities in blood etc.
iv. Gut microbiota profile.
v. Plasma protein profile.

Key secondary outcomes

i. Profiles of gene abnormalities, RNA expression, biomarkers, protein expression, etc. in tumor tissue
And clinical pathological factors, association with clinical course.
ii. Relationship between profile of gene abnormality, RNA expression, biomarker, etc. in ctNA and clinical pathological factors, clinical course.
iii. Relationship between Germline Gene Abnormality Profiles in Blood etc and Clinicopathological Factors and Clinical Course.
iv. Relationship between gut microbiota profile, clinicopathological factors, and clinical course.
v. Associations between plasma protein profiles, clinicopathological factors, and clinical course.


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.At least 18 years old when informed consent is obtained.
2.Histopathologically diagnosed as having advanced solid malignancy.
3.No curative treatment is available.
4.Consent has been obtained in writing from the patient regarding participation in this research.
5.Satisfiesb i, ii or iii below.
i.Before undergoing first-line systemic therapy.
ii.The disease progresses during systemic therapy and the patient is scheduled to undergo designated targeted therapy as the subsequent treatment.
iii. Have a specific genetic abnormality
6.Eastern Cooperative Oncology Group performance status is 0 or 1.
7.Can submit a formalin fixed paraffin embedded (FFPE) sample to this research.
8.Does not have any serious coexisting illness (e.g., poorly controlled diabetes mellitus or infectious disease, symptomatic interstitial pneumonia or pulmonary fibrosis, etc.).
9.Is expected to survive for at least 12 weeks from the enrollment date.
10.Willing to undergo investigative treatment according to the results of tissue genome profiling, blood genome profiling, reproductive cell lineage profiling and/or IHC.

Key exclusion criteria

1.Has a history of undergoing allogeneic hematopoietic stem cell transplantation or organ transplantation.
2.Is pregnant.
3.Has a history of another malignant tumor within the three years prior to enrollment.
4.Is judged to be ineligible for enrollment in this research by the study doctor.

Target sample size

2750


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 for the Promotion of Drug and Diagnostic Development

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan

TEL

04-7133-1111

Email

tyoshino@east.ncc.go.jp


Public contact

Name of contact person

1st name Takao
Middle name
Last name Fujisawa

Organization

National Cancer Center Hospital East

Division name

Department of Head and Neck Medical Oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan

TEL

04-7133-1111

Homepage URL


Email

tafujisa@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



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 Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@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

国立がん研究センター東病院(千葉県)、愛知県がんセンター(愛知県)、大阪大学医学部附属病院(大阪府)、金沢大学附属病院(石川県)、がん研究会有明病院(東京都)、杏林大学医学部付属病院(東京都)、国立病院機構九州がんセンター(福岡県)、慶應義塾大学病院(東京都)、近畿大学病院(大阪府)、埼玉県立がんセンター(埼玉県)、国立病院機構四国がんセンター(愛媛県)、静岡県立静岡がんセンター(静岡県)、聖マリアンナ医科大学病院(神奈川県)、千葉県がんセンター(千葉県)、北海道大学病院(北海道)、筑波大学附属病院(茨城県)、関西労災病院(大阪府)、九州大学病院(福岡県)、神奈川県立病院機構神奈川県立がんセンター(神奈川県)、大阪医療センター(大阪府)、香川大学医学部附属病院(香川県)、埼玉医科大学国際医療センター(埼玉県)、神戸市立医療センター中央市民病院(兵庫県)、岐阜大学医学部附属病院(岐阜県)、大阪医科薬科大学病院(大阪府)、島根県立中央病院(島根県)、関西医科大学附属病院(大阪府)、京都桂病院(京都府)、大阪国際がんセンター(大阪府)、大阪急性期・総合医療センター(大阪府)、三重大学医学部附属病院(三重県)、済生会福岡総合病院(福岡県)、徳島大学病院(徳島県)、広島大学病院(広島県)、市立豊中病院(大阪府)、東京慈会恵医科大学附属病院(東京都)、独立行政法人地域医療機能推進機構九州病院(福岡県)、鳥取大学医学部附属病院(鳥取県)、中部国際医療センター(岐阜県)、藤田医科大学病院(愛知県)、宝塚市立病院(兵庫県)、横浜市立大学附属市民総合医療センター(神奈川県)、松江市立病院(島根県)、高知大学医学部附属病院(高知県)、東北大学病院(宮城県)、虎の門病院(東京都)、亀田総合病院(千葉県)、倉敷中央病院(岡山県)


Other administrative information

Date of disclosure of the study information

2021 Year 04 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

Open public recruiting

Date of protocol fixation

2021 Year 03 Month 19 Day

Date of IRB

2021 Year 03 Month 19 Day

Anticipated trial start date

2021 Year 05 Month 20 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This research is observational research to evaluate the profiles of genetic abnormalities, RNA expression, and biomarkers in tumor tissue and ctNA and the profiles of germline genetic abnormalities in blood evaluated with blood genome profiling, and the results of protein expression in tumor tissue evaluated with tissue genome profiling and IHC, and the like, in terms of their relationship with clinical pathological factors, clinical course, etc.


Management information

Registered date

2021 Year 04 Month 12 Day

Last modified on

2023 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name