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Chromosome aberration analysis of peripheral lymphocytes for the patients who was diagnosed as uterine corpus cancer an receiving adjuvant radiation therapy

Status Approved

First Submitted Date

2021/03/18
Registered Date

2021/04/05
Last Updated Date

2022/08/17

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006052
Unique Protocol ID	KIRAMS 2018-10-008-005
Public/Brief Title	Chromosome aberration analysis of peripheral lymphocytes for the patients who was diagnosed as uterine corpus cancer and receiving adjuvant radiation therapy
Scientific Title	Chromosome aberration analysis of peripheral lymphocytes for the patients who was diagnosed as uterine corpus cancer an receiving adjuvant radiation therapy
Acronym	CART-uterus
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KIRAMS 2018-10-008-005
Approval Date	2021-02-22
Institutional Review Board Name	Korea Cancer Center Hospital Institutional Review Board
Institutional Review Board Address	75, Nowon-ro, Nowon-gu, Seoul
Institutional Review Board Telephone	02-970-1389
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Hyo-Rak Lee
Title	MD
Telephone	+82-2-3399-5802
Affiliation	Korea Cancer Center Hospital
Address	75, Nowon-ro, Nowon-gu, Seoul, South Korea
Contact Person for Public Queries
Name	Yang Hee Lee
Title	medical technologist
Telephone	+82-2-3399-5957
Affiliation	Korea Cancer Center Hospital
Address	75, Nowon-ro, Nowon-gu, Seoul, South Korea
Contact Person for Updating Information
Name	Yang Hee Lee
Title	Medical technologist
Telephone	+82-2-3399-5957
Affiliation	Korea Cancer Center Hospital
Address	75, Nowon-ro, Nowon-gu, Seoul, South Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-12-20 Actual
Target Number of Participant	12
Primary Completion Date
Study Completion Date
Name of Study	Korea Cancer Center Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-12-20 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Cancer Center Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea Cancer Center Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Cytogenetic biodosimetry is to estimate absorbed dose by measuring the frequency of chromosome aberrations such as dicentrics and translocations. Since the estimated dose is converted from chromosomal aberration frequency according to dose-response curve, it is important to generate accurate curves. Generally, dose response curve is produced using homogeneously irradiated human blood ex vivo - assuming whole body exposure. However, significant cases of partial body exposure occurs in real radiological accidents. Therefore it is necessary to validate the dose estimation procedures using heterogeneously irradiated samples in vivo. Our institute performs dose assessment and medical procedures for exposed victims in radiological accidents. We aims to validate our dose estimation system for application in a real radiological accident. For achieving this goal, we will analyze the correlation between estimated dose according to our in vitro dose response curve and irradiated physical dose of patients who was diagnosed as uterine corpus cancer and receiving radiotherapy, which causes partial body irradiation. In addition, we will evaluate the levels of gene expression and extracellular vesicles and suggest candidates for potential radiation biomarkers. Study population is consist of patients who was diagnosed as uterine corpus cancer and receiving adjuvant radiation therapy, and target number of participants is 12. Blood samples will be collected from patients 9 times before, during, after radiotherapy. Changes in blood cell count, chromosome aberrations (dicentrics, translocation), gene expression, extracellular vesicles will be assessed. Patients who singed in written informed consent form to participate in this study after receiving explanation about study goal and procedure will be enrolled. This study would provide valuable information on dose assessment for victims overexposed to radiation and time-kinetics of radiation-induced chromosome aberrations.

Study Summary Information

Lay Summary

Cytogenetic biodosimetry is to estimate absorbed dose by measuring the frequency of chromosome aberrations such as dicentrics and translocations. Since the estimated dose is converted from chromosomal aberration frequency according to dose-response curve, it is important to generate accurate curves. Generally, dose response curve is produced using homogeneously irradiated human blood ex vivo - assuming whole body exposure. However, significant cases of partial body exposure occurs in real radiological accidents. Therefore it is necessary to validate the dose estimation procedures using heterogeneously irradiated samples in vivo.
Our institute performs dose assessment and medical procedures for exposed victims in radiological accidents. We aims to validate our dose estimation system for application in a real radiological accident. For achieving this goal, we will analyze the correlation between estimated dose according to our in vitro dose response curve and irradiated physical dose of patients who was diagnosed as uterine corpus cancer and receiving radiotherapy, which causes partial body irradiation. In addition, we will evaluate the levels of gene expression and extracellular vesicles and suggest candidates for potential radiation biomarkers.
Study population is consist of patients who was diagnosed as uterine corpus cancer and receiving adjuvant radiation therapy, and target number of participants is 12. Blood samples will be collected from patients 9 times before, during, after radiotherapy. Changes in blood cell count, chromosome aberrations (dicentrics, translocation), gene expression, extracellular vesicles will be assessed. Patients who singed in written informed consent form to participate in this study after receiving explanation about study goal and procedure will be enrolled.
This study would provide valuable information on dose assessment for victims overexposed to radiation and time-kinetics of radiation-induced chromosome aberrations.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Prospective
Target Number of Participant	12
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Patients who was diagnosed as uterine corpus cancer and receiving adjuvant radiation therapy
Cohort/ Group 1	Cohort/Group Description Changes in blood cell count, chromosome aberrations (dicentrics, translocation), gene expression, extracellular vesicles will be assessed before, during, and after radiotherapy (9 times). Information on factors which may affect chromosome aberration frequency - i.e., radiation exposure, smoking history and etc. - will be collected by interviewing patients.
Biospecimen Collection & Archiving	: DNA Collect & Archive: Sample without DNA
Biospecimen Description	White blood cells, plasma, RNA

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients who was diagnosed as uterine corpus cancer and receiving adjuvant radiation therapy
Sampling Method	Patients who singed in written informed consent form to participate in this study after receiving explanation about study goal and procedure will be enrolled.
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C54.9)Malignant neoplasm of corpus uteri, unspecified Patients who was diagnosed as uterine corpus cancer and receiving adjuvant radiation therapy
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 19Year~No Limit
	Description 1. Female patients, age ≥ 19 years 2. Patients with 0-2 Eastern Cooperative Oncology Group (ECOG) score 3. Patients who was diagnosed as uterine corpus cancer and receiving surgery 4. Patients who singed in written informed consent form to participate in this study after receiving explanation about study goal and procedure
Exclusion Criteria	1. Patients who are pregnant or breastfeeding 2. Patients who previously received chemotherapy or radiotherapy 3. Patients whose treatment area is not whole pelvic 4. Patients whose daily dose is not 1.8 Gy 5. Patients whose total treatment dose is not 50.4 Gy or patients who received brachytherapy
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Dicentric freqency
Timepoint	9 times before, during, after radiotherapy
Secondary Outcome(s) 1
Outcome	translocation frequency
Timepoint	9 times before, during, after radiotherapy

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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