UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051550 |
|---|---|
| Receipt number | R000058813 |
| Scientific Title | A real-world analysis of anamorelin in patients with advanced cancer; A Multicenter, Retrospective Cohort Study |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2023/07/07 18:16:36 |
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Basic information
Public title
A real-world analysis of anamorelin in patients with advanced cancer; A Multicenter, Retrospective Cohort Study
Acronym
HGCSG2201
Scientific Title
A real-world analysis of anamorelin in patients with advanced cancer; A Multicenter, Retrospective Cohort Study
Scientific Title:Acronym
HGCSG2201
Region
| Japan |
Condition
Condition
cancer cachexia
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the treatment outcomes of anamorelin hydrochloride in patients with advanced cancers in real world setting, and to explore the factors which relates to its efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in FAACT appetite-related scores before and after starting anamorelin hydrochloride
Key secondary outcomes
1)Change in body weight (kg) before and after starting anamorelin hydrochloride
2)Change in ECOG PS after anamorelin hydrochloride initiation
3)Frequency of anamorelin-related adverse events
4)Change in FAACT appetite-related score after anamorelin hydrochloride initiation by patient's background
5)Weight change after anamorelin hydrochloride initiation by patient's backgrounds
6)Change in ECOG PS after starting anamorelin hydrochloride by patient's backgrounds
7)Frequency of adverse events attributable to anamorelin hydrochloride by patient's backgrounds
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who were treated with anamorelin hydrochloride between April-November 2021.
2)Age <=20 years old at the time of initiation of anamorelin hydrochloride.
Key exclusion criteria
1)Participation in the clinical trial is determined as unsuitable.
Target sample size
176
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Division of cancer center
Zip code
060-8648
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Harada |
Organization
Hokkaido university hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
0608638
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL
0117065657
Homepage URL
haraharaccho0605@yahoo.co.jp
Sponsor or person
Institute
Hokkaido Gastrointestinal Cancer Study Group
Institute
Department
Personal name
Kazuaki Harada
Funding Source
Organization
Hokkaido Gastrointestinal Cancer Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Toyama University Hospital, Hirosaki University Hospital, Kushiro Rosai Hospital, Hakodate Municipal Hospital, Sapporo City General Hospital, Tonan Hospital, Hokkaido Medical Center, Wakkanai Municipal Hospital, Hakodate Central General Hospital, Sapporo Medical Center NTT EC, Miyazaki University Hospital, Iwamizawa Municipal General Hospital, Tomakomai City Hospital, Tokushukai Medical Corporation Sapporo Higashi Tokushukai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 10 | 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
176
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
| 2023 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective Cohort Study
Management information
Registered date
| 2023 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058813
