UMIN-CTR Clinical Trial

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
Last 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
Email	nishikawak@oita-u.ac.jp

Public contact
1st 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
Email	nishikawak@oita-u.ac.jp

Sponsor
Institute	Oita University Faculty Of Medicine Graduate School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010551