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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034972
Receipt No. R000039876
Scientific Title A retrospective cohort study to investigate the incidence of cachexia in pancreatic cancer patients
Date of disclosure of the study information 2018/11/26
Last modified on 2018/11/22

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Basic information
Public title A retrospective cohort study to investigate the incidence of cachexia in pancreatic cancer patients
Acronym A retrospective cohort study to investigate the incidence of cachexia in pancreatic cancer patients
Scientific Title A retrospective cohort study to investigate the incidence of cachexia in pancreatic cancer patients
Scientific Title:Acronym A retrospective cohort study to investigate the incidence of cachexia in pancreatic cancer patients
Region
Japan

Condition
Condition Pancreatic Cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the frequency of onset and the time to onset of cancer cachexia by a retrospective cohort study, in patients who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy.
Basic objectives2 Others
Basic objectives -Others Retrospective observation study
Trial characteristics_1
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The frequency of onset and the time to onset of cancer cachexia, in patients who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy
Key secondary outcomes 1) Relationship between onset of cancer cachexia and changes in laboratory parameter
2) Relationship between cancer cachexia and overall survival
3) Relationship between cancer cachexia and the continuation rate of anticancer chemotherapy
4) Relationship between cancer cachexia and the introduction rate of secondary therapy
5) Relationship between onset of cancer cachexia and introduction rate of tertiary therapy
6) Relationship between cancer cachexia and severity and incidence of anorexia and fatigue
7) Correlation between the changes in body weight of >= 5% or (if BMI> 20 kg/m2 or sarcopenia) weight loss of > 2% and changes in each laboratory parameter during the first systemic chemotherapy period at 12-week intervals evaluated from the beginning day of the first systematic chemotherapy.
8) Correlation between the changes in body weight of >= 5% or (if BMI> 20 kg/m2 or sarcopenia) weight loss of > 2% and the severity and incidence of adverse event (neutropenia, anemia, thrombocytopenia, febrile neutropenia, anorexia, nausea, diarrhea, fatigue, peripheral sensory neuropathy, skin rash) during the first systemic chemotherapy period at 12-week intervals evaluated from the beginning day of the first systemic chemotherapy.
9) The results of primary and secondary endpoints are stratified by the regimen of initial systemic chemotherapy.

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 Patients who satisfy all the following items are included.
1) Patients who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy
2) Patients who have pathologic diagnosis that is consistent with invasive pancreatic ductal carcinoma
3) Patients who were measured body weight periodically at the beginning of the initial systemic chemotherapies and during the subsequent medical consultation period
4) Received one of the following cancer chemotherapies during the study period
- mFOLFIRINOX
- GEM+nab-PTX
- GEM
- GEM+ERL
5) Patients who have not refused secondary use of the clinical information, or participated in the 19-075 Study, the K2011-001 Study, and 2012-0281 Study conducted at the National Cancer Center Hospital East and agreed to secondary use of the existing information
Key exclusion criteria Patients who meet at least one of the following exclusion criteria are not included.
1) Patient who underwent surgical operation of the gastrointestinal tract within the last 6 months starting from the beginning day of the first systemic chemotherapy excluding stent placement in the duodenum or gastrojejunostomy
2) Patients with simultaneously active, double cancer (Stage I intraepithelial carcinoma, intramucosal carcinoma, superficial bladder carcinoma, or other cancers without recurrence for 5 years or more can be registered)
3) Patients with missing of body weight data over 12 weeks in the medical consultation period after the beginning of initial systemic chemotherapy
4) Patients who underwent puncture for ascitic fluid at the beginning of initial systemic chemotherapy
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Machii
Organization ONO PHARMACEUTICAL CO., LTD.
Division name Section 2 Medical Planning I Medical Affairs
Zip code
Address 8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi 541-8564, Japan
TEL 06-6263-2992
Email machii@ono.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Mitsunaga
Organization National Cancer Center Hospital East
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba-ken, 277-8577 Japan
TEL 04-7133-1111
Homepage URL
Email smitsuna@east.ncc.go.jp

Sponsor
Institute ONO PHARMACEUTICAL CO., LTD.
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 11 Month 26 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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This retrospective observational study is carried out on clinical data collected using the EDC from the medical record of subjects. Patients who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy at the site by 31 March 2017 are included in the study. Patient enrolment is based on a definitive diagnosis in the medical record. The medical records are collected for at least 1 year (maximum 3 years) from the date of the initial systemic chemotherapy.

<Contents collected>
1) Baseline characteristics (At the time of initial systemic chemotherapy)
Age, birth year/month, sex, height, body weight, the heaviest body weight in the last 6 months from the beginning day of the first systemic chemotherapy, complications , ECOG PS, primary lesion (pancreatic head, body, and tail), UICC staging, ascites, laboratory parameter (Na, K, AST, ALT, AL-P, t-Bil, Neu, WBC, Plt, Cre, Alb, TP, TLC, CRP, Hb, ChE, Glu), tumor maker (CA19-9), CTL3-SMI, Anorexia, fatigue, adverse events (Neutropenia, febrile neutropenia, anemia, platelet count reduction, nausea, diarrhea, peripheral sensory neuropathy, and rash) at the beginning of initial systemic chemotherapy
2) Clinical information collected every 4-week from the initial systemic chemotherapy
Body weight
3) Clinical information collected every 12-week from the initial systemic chemotherapy
ECOG PS, laboratory parameter, tumor maker, CTL3-SMI, anorexia, fatigue, adverse events during the initial systemic chemotherapy
4) Clinical information collected from all the consultation period
- Initial chemotherapy [Regimen, initial/final date, reason for discontinuation, confirmation date of exacerbation, antitumor effect (RECIST ver1.1)]
- Secondary/tertiary chemotherapy and if not done, the reason (Regimen, initial/final date)
- Final outcome (Survival, death, lost to follow-up)

Management information
Registered date
2018 Year 11 Month 22 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039876

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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