UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052426 |
|---|---|
| Receipt number | R000059837 |
| Scientific Title | Assessment of clinical and radiological findings for risk evaluation of secondary interstitial lung diseases associated with cancer treatments |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2023/10/05 15:56:30 |
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Basic information
Public title
Assessment of clinical and radiological findings for risk evaluation of secondary interstitial lung diseases associated with cancer treatments
Acronym
ACROSS study
Scientific Title
Assessment of clinical and radiological findings for risk evaluation of secondary interstitial lung diseases associated with cancer treatments
Scientific Title:Acronym
ACROSS study
Region
| Japan |
Condition
Condition
Patients with cancer or suspected cancer who have interstitial lung lesions
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study prospectively observe patients scheduled or undergoing cancer treatment and have interstitial lung lesions on chest HRCT to identify risk factors for lung injury due to cancer treatment.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cumulative incidence of lung injury: The cumulative incidence of lung injury is determined by the Gray test, from the date of enrollment to the occurrence of lung injury. Death from any cause is treated as a competing risk.
Key secondary outcomes
Analysis of risk factors for lung injury: obtained by univariate and multivariate Fine-Gray tests.
Analysis of risk factors for lung injury by cancer treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be enrolled:
1. Patients with a diagnosis or clinical suspicion of cancer.
2. Patients with findings on chest CT that suggest lung fibrosis.
3. Patients who are scheduled for or undergoing treatment for cancer (surgery, radiation, or drug therapy).
4. Patients who have given their consent to participate in this study by signing a consent form in person.
5. 5. 18 years old or older
Key exclusion criteria
Patients with any of the following will not be included in the study:
1. patients with no diagnosis or clinical suspicion of cancer
2. patients with no evidence of fibrosis on chest CT
3. patients who are not scheduled for treatment for cancer
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Respiratory Medicine
Zip code
431-3192
Address
Handayama 1-20-1, Hamamatsu, Japan
TEL
053-435-2111
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Karayama |
Organization
Hamamatsu University School of Medicine
Division name
Cancer Center
Zip code
431-3192
Address
Handayama 1-20-1, Hamamatsu, Japan
TEL
053-435-2111
Homepage URL
karayama@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hamamatsu University School of Medicine
Address
Handayama 1-20-1, Hamamatsu, Japan
Tel
053-435-2680
rinri@hama-med.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 | 10 | 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
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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection:
[Registration form]: age, sex, cancer type, stage, planned treatment, planned treatment start date, height, weight, ECOG-PS, mMRC, symptoms, SpO2 (or PaO2), smoking history, history of radiation therapy to the chest, lung function tests (FVC, FEV1, FEV1/FVC, DLCO), blood (FVC, FEV1, FEV1/FVC, DLCO), blood tests (general tests, LDH, KL-6, Sp-D, various autoantibodies), chest CT (CD-ROM).
[CRF]: Date of cancer diagnosis, organ, histological type, oncogene, PD-L1, stage, metastatic organs, history/complications, concomitant medications, past anticancer drug treatment, past radiation therapy, blood tests (general examination, LDH, KL-6, Sp-D, various autoantibodies), lung function tests (FVC, FEV1, FEV1/FVC, DLCO), cancer treatment, and outcome on last visit.Cancer treatment details, outcome on the last visit, (only in cases of occurrence of lung injury) date of diagnosis of lung injury, symptoms, mMRC, ECOG-PS, SpO2 (or PaO2), severity of lung injury, blood tests (general examination, LDH, KL-6, Sp-D, various autoantibodies), lung function tests (FVC, FEV1, FEV1/FVC, DLCO), chest CT (CD-ROM), treatment details of lung injury, treatment evaluation of lung injury, (only in cases of relapse of lung injury) date of diagnosis of relapse, symptoms, mMRC, ECOG-PS, SpO2 (or PaO2), severity of lung injury at relapse, blood tests (general examination, LDH, KL-6, Sp-D, various autoantibodies), lung function tests (FVC, FEV1, FEV1/FVC, DLCO), chest CT (CD-ROM), treatment details at relapse, treatment evaluation after relapse
Management information
Registered date
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059837
| Research Plan | |
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| Registered date | File name |
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