UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055740 |
|---|---|
| Receipt number | R000063696 |
| Scientific Title | Prospective observational study on the relationship between preoperative chemotherapy and risk of thrombosis in pancreatic cancer |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2024/10/04 10:35:38 |
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Basic information
Public title
Prospective study on the relationship between preoperative chemotherapy and risk of thrombosis in pancreatic cancer
Acronym
Prospective study on the relationship between preoperative chemotherapy and risk of thrombosis in pancreatic cancer
Scientific Title
Prospective observational study on the relationship between preoperative chemotherapy and risk of thrombosis in pancreatic cancer
Scientific Title:Acronym
Prospective study on the relationship between preoperative chemotherapy and risk of thrombosis in pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk of thrombosis in patients with resectable or borderline resectable pancreatic cancer who are scheduled to receive neoadjuvant chemotherapy
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of thrombosis(after neoadjuvant chemotherapy, perioperative period)
Key secondary outcomes
1)Changes in Tissue factor(TF), Procoagulant activity(PCA), D-dimer and CA19-9 before and after preoperative chemotherapy and after surgery.
2)Relationship between TF, PCA, D-dimer, CA19-9 and the development of thrombosis.
3)Relationship between the efficacy of neoadjuvant chemotherapy and TF, PCA, D-dimer, CA19-9, and the development of thrombosis.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Pathologically or clinically diagnosed with pancreatic cancer.
2)Patients with resectable or borderline resectable pancreatic cancer who are scheduled for neoadjuvant chemotherapy.
Key exclusion criteria
1)Patients who have a history of thrombosis within 5 years prior to enrollment, or who currently have a thrombosis.
2)Patients with contrast allergies.
3)Patients already taking anticoagulants.
4)Patients with obstructive jaundice or pancreatitis who are not expected to improve.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Yamamoto |
Organization
Kanagawa Cancer Center
Division name
Gastrointestinal surgery (Hepato-Biliary-Pancreatic)
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama
TEL
045-520-2222
yamamoton@kcch.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kamiya |
Organization
Kanagawa Cancer Center
Division name
Gastrointestinal surgery (Hepato-Biliary-Pancreatic)
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama
TEL
045-520-2222
Homepage URL
kamiya.1c90o@kanagawa-pho.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Research Ethics Committee of Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama, 241-8515
Tel
045-520-2222
clinical_trials@kcch.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
神奈川県立がんセンター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The risk of developing venous thromboembolism (VTE) increases by 4 to 7 folds in cancer patients compared to non-cancer patients. In particular, pancreatic cancer patients are at the highest risk of developing VTE. VTE is one of the most critical complications of cancer patients, it affects patient quality of life and the completion of treatment.
In this study, we will monitor the onset of VTE in pancreatic cancer patients scheduled to receive neoadjuvant chemotherapy (NAC), measure tissue factor (TF), procoagulant activity (PCA), D-dimer, CA19-9 and TFPI2, which may predict the onset of VTE, and examine the relationship between these factors and the onset of VTE. Identifying the mechanisms and predictors of VTE during NAC may lead to safer continuation of NAC through VTE prevention and treatment interventions.
Management information
Registered date
| 2024 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063696
