UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045114
Receipt number R000051486
Scientific Title Frequent post-operative monitoring of colorectal cancer using individualized ctDNA validated by multi-regional molecular profiling
Date of disclosure of the study information 2021/08/15
Last modified on 2021/08/10 17:43:57

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Basic information

Public title

Frequent post-operative monitoring of colorectal cancer using individualized ctDNA validated by multi-regional molecular profiling

Acronym

Circulating tumor DNA monitoring in colorectal cancer

Scientific Title

Frequent post-operative monitoring of colorectal cancer using individualized ctDNA validated by multi-regional molecular profiling

Scientific Title:Acronym

Circulating tumor DNA monitoring in colorectal cancer

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The aim of this study is to elucidate clinical validities of circulating tumor DNA (ctDNA) monitoring by digital PCR using individual tumor-specific mutations in post-operative survey of colorectal cancer patients.

Basic objectives2

Others

Basic objectives -Others

The aim of this study is to elucidate whether frequent tumor burden monitoring with ctDNA of a small number of individual tumor-specific mutations using digital PCR provides clinically useful information in post-operative survey of colorectal cancer patients. With longitudinal ctDNA monitoring during treatment in addition to routine surveillance, ctDNA dynamics and clinical relapse by conventional surveillance modalities are compared if ctDNA provides useful information such as the early detection of relapse.To verify the effect of tumor genetic and proteomic heterogeneity in regard to circulating tumor DNA (ctDNA) by multiregional sequencing and proteomic analysis of primary colorectal cancer.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

ctDNA dynamics and clinical relapse by conventional surveillance modalities are compared if ctDNA provides useful information on the early detection of relapse.

Key secondary outcomes

1. Association of pre-treatment ctDNA detection and tumor genetic and proteomic heterogeneity
2. ctDNA monitoring and disease-free confirmation
3. Pretreatment ctDNA detection and overall survival
4. Pretreatment ctDNA detection and disease free survival
5. ctDNA dynamics and treatment efficacy
6. Specificity and sensitivity of ctDNA test for relapse


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

Pre-operative colorectal cancer patients with clinical Stage II or higher. 1. Patients must have given written an informed consent
2. Histologically confirmed colorectal cancer

Key exclusion criteria

1. Patients who do not wish to pursue standard of care therapy 2. patients who are considered ineligible for enrolling the study by a principal investigator or sub-investigator

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name S.
Last name Nishizuka

Organization

Iwate Medical University Institute for Biomedical Sciences

Division name

Division of Biomedical Research and Development

Zip code

0283695

Address

1-1-1 Idaidori, Yahaba, Iwate

TEL

0196515111

Email

snishizu@iwate-med.ac.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Iwaya

Organization

Iwate Medical University Hospital

Division name

Department of Surgery

Zip code

0283695

Address

2-1-1 Idaidori, Yahaba, Iwate

TEL

0196137111

Homepage URL


Email

tiwaya@iwate-med.ac.jp


Sponsor or person

Institute

Iwate Medical University

Institute

Department

Personal name



Funding Source

Organization

Iwate Medical University

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

Iwate Medical University

Address

1-1-1 Idaidori, Yahaba, Iwate

Tel

0196515111

Email

snishizu@iwate-med.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

2021 Year 08 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://www.nature.com/articles/s41416-021-01266-4

Number of participants that the trial has enrolled

12

Results

Founder mutations, defined as a mutation that is present in all regions of the tumor in a binary manner, were identified in 12/14 tumors. In contrast, truncal mutations, which are the first mutations that occur prior to divergence of branches in the phylogenetic tree using variant allele frequency as continuous variables, were identified in 12/14 tumors. Most founder and truncal mutations exhibited high VAFs and more likely to be detected as ctDNA.

Results date posted

2021 Year 08 Month 09 Day

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

Enrolling by invitation

Date of protocol fixation

2015 Year 11 Month 01 Day

Date of IRB

2015 Year 12 Month 21 Day

Anticipated trial start date

2016 Year 03 Month 11 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In addition to mutation and protein expression profiles, gene expression profiling of primary colorectal cancer will be analyzed.


Management information

Registered date

2021 Year 08 Month 10 Day

Last modified on

2021 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051486


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name