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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018912
Receipt No. 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

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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
Email 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
Email ho.shomu@city.sapporo.jp

Sponsor
Institute Sapporo City General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021816

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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