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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033693
Receipt No. R000038416
Official scientific title of the study A retrospective cohort study to investigate the incidence of cachexia in gastric cancer patients
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/09

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Basic information
Official scientific title of the study A retrospective cohort study to investigate the incidence of cachexia in gastric cancer patients
Title of the study (Brief title) A retrospective cohort study to investigate the incidence of cachexia in gastric cancer patients
Region
Japan

Condition
Condition Gastric 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 unresectable advanced gastric cancer for the first time 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 unresectable advanced gastric cancer for the first time 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, changes in body weight 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 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 diagnosed with progressive gastric cancer that cannot be resected radically
2) Patients who were measured body weight periodically at the time of visit and during the subsequent medical consultation period
3) Received cancer chemotherapy during the study period

Key exclusion criteria Patients who meet at least one of the following exclusion criteria are not included.
1) Patients who underwent surgical operation of the gastrointestinal tract within the last 6 months excluding stent placement in the gastrointestinal tract or gastroduodenostomy
2) Patients with weight loss distinctly caused by a gastrointestinal transit disorder
3) 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)
4) Patients with missing of weight data over 12 weeks at the time of visit and during the subsequent medical consultation period
5) 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 Koji Machii
Organization ONO PHARMACEUTICAL CO., LTD.
Division name Section 2 Medical Planning I Medical Affairs
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 Masaru Fukahori
Organization Kurume University Hospital
Division name Multidisciplinary Cancer Treatment Center
Address 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan
TEL 0942-31-7561
Homepage URL
Email digdug0526@gmail.com

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)

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 08 Month 10 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 05 Month 23 Day
Anticipated trial start date
2018 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This retrospective cohort study is carried out on clinical data collected using the electronic data collection system (EDC) from the medical record of subjects. Patients who were initially diagnosed with advanced gastric cancer that cannot be resected radically prior to August 31, 2016 and who underwent systemic chemotherapy at the sites 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, complications (COPD, diabetes, hypertension, dyslipidemia, hypothyroidism etc.), ECOG PS, primary lesion (gastroesophageal junction, gastric corpus, gastric antrum), pathological classification (tub1, tub2, por1, por2, pap, sig, muc, etc.), UICC staging, metastatic lesion (Lung, liver, bone, brain, distant lymph node, peritoneal metastasis etc.), laboratory parameter (Na, K, AST, ALT, AL-P, t-Bil, Neu, WBC, Plt, Cre, Alb, TLC, CRP, Hb), tumor marker (CA19-9, CEA), IVH, stoma (Ileum, colon), fatigue and anorexia
2) Clinical information collected every 4-week from the initial systemic chemotherapy
Body weight, ECOG PS, laboratory parameter, tumor marker, fatigue and anorexia, surgery related to the primary disease, severe ascites, IVH, stoma
3) Clinical information collected from all the consultation period
- Initial systemic 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 08 Month 09 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038416

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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