UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018912 |
|---|---|
| Receipt number | R000021816 |
| Scientific Title | Thromboembolism Incidence in Patients with Gastrointestinal Tract Cancer Receiving Chemotherapy: A Single-institusional Retrospective Cohort Analysis (Sapporo CAT study) |
| Date of disclosure of the study information | 2015/09/04 |
| Last modified on | 2019/09/09 16:07:45 |
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Basic information
Public title
Thromboembolism Incidence in Patients with Gastrointestinal Tract Cancer Receiving Chemotherapy: A Single-institusional Retrospective Cohort Analysis (Sapporo CAT study)
Acronym
Sapporo CAT study
Scientific Title
Thromboembolism Incidence in Patients with Gastrointestinal Tract Cancer Receiving Chemotherapy: A Single-institusional Retrospective Cohort Analysis (Sapporo CAT study)
Scientific Title:Acronym
Sapporo CAT study
Region
| Japan |
Condition
Condition
Gastrointestinal tract cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the thromboembolism incidence of gastrointestinal tract cancer patients receiving chemotherapy in a Japanese community hospital's daily practice setting.
Basic objectives2
Others
Basic objectives -Others
retrospective cohort study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of thromboembolism in gastrointestinal tract cancer patients receiving chemotherapy.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the patients received chemotherapy for gastrointestinal tract cancer in Sapporo City General Hospital from January 2008 to May 2015.
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Nakamura |
Organization
Sapporo City General Hospital
Division name
Gastroenterology
Zip code
0608604
Address
1-1, Nishi 13 chome, Kita 11 jo, Chuo-ku, Sapporo, JAPAN
TEL
011-726-2211
michio.nakamura@doc.city.sapporo.jp
Public contact
Name of contact person
| 1st name | Ryouta |
| Middle name | |
| Last name | Hayashi |
Organization
Sapporo City General Hospital
Division name
General Affairs Section
Zip code
0608604
Address
1-1, Nishi 13 chome, Kita 11 jo, Chuo-ku, Sapporo, JAPAN
TEL
011-726-2211
Homepage URL
ho.shomu@city.sapporo.jp
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo City General Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo City General Hospital
Address
1-1, Kita 11 jo Nishi 13 chome, Chuo-ku, Sapporo
Tel
011-726-2211
011-726-9541
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
| 2015 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
https://datadryad.org/resource/doi:10.5061/dryad.84s01sv/1
Publication of results
Published
Result
URL related to results and publications
https://bmjopen.bmj.com/content/bmjopen/9/8/e028563.full.pdf
Number of participants that the trial has enrolled
500
Results
Results Of the 500 patients, 70 patients (14.0%) developed TE during the follow-up period.
Results date posted
| 2019 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 22 | Day |
Baseline Characteristics
We investigated all patients who started chemotherapy as adjuvant (Adj) or non-Adj treatment for GC and colorectal cancer (CRC) between January 2008 and May 2015 using our hospital data warehouse.
Participant flow
We included patients who developed TE within 1 month before starting chemotherapy and excluded patients who developed TE more than 1 month before starting chemotherapy. The cut-off date for follow-up was 31 May 2016.
Adverse events
Among the 500 GCC patients included in this study, TE was detected in 70 (14.0%) patients. The rate of TEi was 9.2% (19/206) in GC patients and 17.3% (51/294) in CRC patients, with a statistically significant difference (p=0.010).
Outcome measures
The primary objective of this study was to investigate TEi in GCC patients who received chemotherapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
All the patients received chemotherapy for gastrointestinal tract cancer in Sapporo City General Hospital from January 2008 to May 2015 were indentified through medical records reviews.
Management information
Registered date
| 2015 | Year | 09 | Month | 04 | Day |
Last modified on
| 2019 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021816
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| Registered date | File name |
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