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
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
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
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
