UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017460 |
|---|---|
| Receipt number | R000007867 |
| Scientific Title | A study on the detection of circulating tumor cells (CTC) in patients with resected pulmonary metastases from colorectal cancer and its clinical significance as a biomarker |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/12/09 19:50:37 |
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Basic information
Public title
A study on the detection of circulating tumor cells (CTC) in patients with resected pulmonary metastases from colorectal cancer and its clinical significance as a biomarker
Acronym
CTC detection in patients with resected pulmonary metastases from colorectal cancer
Scientific Title
A study on the detection of circulating tumor cells (CTC) in patients with resected pulmonary metastases from colorectal cancer and its clinical significance as a biomarker
Scientific Title:Acronym
CTC detection in patients with resected pulmonary metastases from colorectal cancer
Region
| Japan |
Condition
Condition
Pulmonary metastases from colorectal cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the circulating tumor cells (CTC) positivity rate and prognosis; to explore whether the positivity rate might serve as a predictive factor for tumor recurrence in patients with solitary pulmonary metastasis (PM) from colorectal cancer (CRC); and to assess the necessity of postoperative adjunctive chemotherapy in CTC-negative patients. To begin with, however, the CTC positivity rate for a small number of cases and its correlation with the clinical factors, which are generally recognized as prognostic factors, will be investigated inasmuch as the CTC positivity rate for patients having undergone resection of PM from CRC has not been fully clarified.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CTC positivity rate for patients having undergone resection of PM from CRC
Key secondary outcomes
Relationship of the CTC positivity rate with postoperative recurrence and prognosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Peripheral blood samples will be drawn from CRC patients with PM prior to operation and will be tested for CTC enumeration.
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
1. Patients with metachronous PM after complete resection of CRC (cancer of the colon, cancer of the rectum) in whom the metastatic lesions are judged to be completely resectable
2. Patients with no evidence of non-PM including resectable hepatic metastasis and with no history of treatment of metastasis
3. Patients with adequate major organ functions and with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 who are judged capable of tolerating a major operation
4. Patients who personally have given informed consent in writing
Key exclusion criteria
1. History of pulmonary resection or lung radiofrequency ablation (RFA) / radiation therapy at the time of enrollment
2. Serious drug allergy
3. Chest X-ray evidence of interstitial pneumonia or pulmonary fibrosis
4. Any or suspected intercurrent active infection
5. Pregnant women, nursing mothers, possibly pregnant women, and women with no intention of practicing contraception
6. Ongoing continuous treatment with systemic corticosteroid medication
7. Poorly controlled diabetes mellitus or any serious complication such as a cardiac disorder
8. History of active double cancer
*Except for malignancies clinically judged to be non-invasive cancer such as carcinoma in situ
*Except for malignancies which have not recurred in >5 years after radical treatment
9. Patients likely to be unable to personally give written informed consent and any other condition that the investigator feels would be inadequate for the safe conduct of this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Saisho |
Organization
Kawasaki Medical School
Division name
Department of General Thoracic Surgery
Zip code
Address
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL
086-462-1111
s.saisho@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Saisho |
Organization
Kawasaki Medical School
Division name
Department of General Thoracic Surgery
Zip code
Address
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL
086-462-1111
Homepage URL
http://www.kawasaki-m.ac.jp/gts/
s.saisho@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School, Department of General Thoracic Surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 08 | 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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007867
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| Registered date | File name |
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| Registered date | File name |
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