UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009012 |
|---|---|
| Receipt number | R000010551 |
| Scientific Title | Influence of regulatory T cells on resistance mechanisms to epidermal growth factor receptor inhibitors: an observational study |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2019/04/12 10:34:56 |
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Basic information
Public title
Influence of regulatory T cells on resistance mechanisms to epidermal growth factor receptor inhibitors: an observational study
Acronym
INTREPID-i (INfluence of Treg on Resistance mechanism to EPIDermal growth factor receptor inhibitors) study
Scientific Title
Influence of regulatory T cells on resistance mechanisms to epidermal growth factor receptor inhibitors: an observational study
Scientific Title:Acronym
INTREPID-i (INfluence of Treg on Resistance mechanism to EPIDermal growth factor receptor inhibitors) study
Region
| Japan |
Condition
Condition
Lung cancer and colon cancer treated with epidermal growth factor receptor inhibitors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate how regulatory T cells influence on resistance to epidermal growth factor receptor inhibitors
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relevance between Treg distribution in skin/circulation and progression free survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The study is initially limited to patients with adenocarcinoma in lung and colon.
2.All patients are required to be treated with a single agent of EGFR-TKI (gefitinib, erlotinib,afatinib) or EGFR-Ab (cetuximab, panitumumab).
3.Skin damage has to recover to <= Grade 1 or can be distinguish from the adverse effect of prior therapies
4.An Eastern Co- operative Oncology Group performance status of 0, 1 or 2.
5.All patients had adequate hepatic, renal, and bone marrow function.
6.All patients were required to give informed consent.
Key exclusion criteria
1.Patients had a medical history of treatment with gefitinib, erlotinib,afatinib, cetuximab, or panitumumab.
2.The patient has received systemic chemotherapy within 21 days or therapeutic radiation therapy within 14 days prior to the first dose of study therapy. Palliative radiation is permitted.
3.Patients have severe complications, as active infection and poorly controlled diabetes.
4.Patients has allergy, which is expected to interrupt the study.
5.Pregnant women
6.Multiple primary cancer.
7.Patients regularly use corticosteroids and immunosuppressive drugs. Inhalation and topical use are permitted.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Nishikawa |
Organization
Oita University Faculty Of Medicine Graduate School of Medicine
Division name
Department of Medical Oncology & Hematology
Zip code
Address
1-1 Idaigaoka, Hasama-machi Yufu-shi, Oita 879-5593 Japan
TEL
097-586-6275
nishikawak@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Nishikawa |
Organization
Oita University Faculty Of Medicine Graduate School of Medicine
Division name
Department of Medical Oncology & Hematology
Zip code
Address
1-1 Idaigaoka, Hasama-machi Yufu-shi, Oita 879-5593 Japan
TEL
097-586-6275
Homepage URL
nishikawak@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty Of Medicine Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basic design: Single arm.
Randomization: Non-randomized.
Blinding: Open -no one is blinded.
Control: Uncontrolled.
Management information
Registered date
| 2012 | Year | 10 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010551
