UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040059
Receipt number R000045669
Scientific Title A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.
Date of disclosure of the study information 2020/04/06
Last modified on 2023/04/13 19:18:04

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Basic information

Public title

A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.

Acronym

A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.

Scientific Title

A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.

Scientific Title:Acronym

A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.

Region

Japan


Condition

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To review the clinical significance of CA125 in the posterior line of chemotherapy for unresectable advanced/recurrent colorectal cancer in daily clinical practice.

Basic objectives2

Others

Basic objectives -Others

the clinical significance

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Overall Survival, Response rate, Disease control rate, Search for treatment effect predictor and prognostic predictors, treatment effect on ascites


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 of colorectal cancer who were treated with FTD/TPI or Regorafenib.(Patients who received both FTD/TPI and regorafenib in the same case and met other inclusion/exclusion criteria should be enrolled for each treatment.)
2)Patients who have been tested for CA125 within 28 days prior to the start of the above treatment.
3)Age <=20 years old at the time of diagnosis.
4)patients who have not rejected the participation of this study from the research subjects or their agent(person who is thought to be able to speak for the will and interest of the research subject).

Key exclusion criteria

1)Participation in the clinical trial is determined as unsuitable.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Yuki

Organization

Hokkaido University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

060-8648

Address

Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido

TEL

011-716-1161

Email

satoshi-yuuki175@joy.ocn.ne.jp


Public contact

Name of contact person

1st name Ken
Middle name
Last name Ito

Organization

Hokkaido University Hospital

Division name

Cancer Center

Zip code

060-8648

Address

Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido

TEL

011-716-1161

Homepage URL


Email

kenito0421@med.hokudai.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Hokkaido Gastrointestinal Cancer Study Group

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

Clinical Research and Medical Innovation Center, Hokkaido University Hospital

Address

Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido

Tel

011-706-7636

Email

crjimu@huhp.hokudai.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

石川県立中央病院(石川県)、富山赤十字病院(富山県)、糸魚川総合病院(新潟県)、高岡市民病院(富山県)、富山厚生連高岡病院(富山県)、宮崎大学(宮崎大学)、霧島市立医師会医療センター(鹿児島県)、古賀総合病院(宮崎県)、手稲渓仁会病院(北海道)、NTT東日本札幌病院(北海道)、函館中央病院(北海道)、秋田大学医学部付属病院(秋田県)、秋田赤十字病院(秋田県)、市立秋田総合病院(秋田県)、北海道大学病院(北海道)


Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 06 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

180

Results

In this retrospective analysis, baseline CA125 correlated with ascites volume in later line treatment of patients with mCRC, suggesting that increased CA125 may be a predictive and prognostic factor.

Results date posted

2022 Year 10 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

There were 75 patients in the baseline CA125 normal group (group N) and 46 patients in the high group (group H).

Participant flow

We retrospectively analyzed the clinical data of 121 patients who received trifluridine/tipiracil (FTD/TPI) or Regorafenib from January 2012 to May 2018 in 10 centers and had the result of serum CA125 just before the treatment. Patients who had received either FTD/TPI or Regorafenib were excluded.

Adverse events

Data not published

Outcome measures

OS, PFS, ascites changes

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 03 Month 24 Day

Date of IRB

2020 Year 03 Month 31 Day

Anticipated trial start date

2020 Year 04 Month 06 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective Cohort Study


Management information

Registered date

2020 Year 04 Month 04 Day

Last modified on

2023 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045669


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name