UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058535 |
|---|---|
| Receipt number | R000066934 |
| Scientific Title | Prospective Multicenter Observational Study on Cardiac and Pulmonary Complications in Esophageal Cancer Patients Treated with Carbon-Ion Radiotherapy |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/21 17:28:59 |
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Basic information
Public title
Prospective Multicenter Observational Study on Cardiac and Pulmonary Complications in Esophageal Cancer Patients Treated with Carbon-Ion Radiotherapy
Acronym
ESCORT-Heart Lung
Scientific Title
Prospective Multicenter Observational Study on Cardiac and Pulmonary Complications in Esophageal Cancer Patients Treated with Carbon-Ion Radiotherapy
Scientific Title:Acronym
ESCORT-Heart Lung
Region
| Japan |
Condition
Condition
esophagus cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the cardiac and pulmonary effects of carbon-ion radiation therapy for esophageal cancer by evaluating adverse events to the heart and lungs in a multicenter, prospective study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Observation of adverse events in the heart and lungs occurring within 24 months after the end of carbon-ion radiation therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases of carbon-ion radiotherapy for squamous cell carcinoma of the esophagus treated at each joint research institution from the date of approval by the head of each research institution.
Key exclusion criteria
If the patient or their family refuses to provide materials for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Ishikawa |
Organization
National Institutes for Quantum Science and Technology QST Hospital
Division name
Department of Radiology
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3306
ishikawa.hitoshi@qst.go.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Isozaki |
Organization
National Institutes for Quantum Science and Technology QST Hospital
Division name
Department of Radiology
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3306
Homepage URL
isozaki.tetsuro@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Tetsuro ISOZAKI
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology QST Hospital
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-206-3306
isozaki.tetsuro@qst.go.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
千葉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
J-CROS identification number, diagnosis, age, gender, medical history, self-reported symptoms, location and extent of primary lesion, histological type, TNM classification (11th edition of the Cancer Staging Manual), TNM classification (UICC TNM 7th edition), tumor markers (SCC, CYFRA, CEA),pathological examination, carbon-ion radiotherapy dose, adverse events after treatment, recurrence after treatment, and survival after treatment.
Management information
Registered date
| 2025 | Year | 07 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066934
