Erythrocyte DestructionNCT07416045
A Multi-dimensional Evaluation of the Effects of Linear Accelerator X-ray Irradiation on Red Blood Cells
An observational study of Erythrocyte Destruction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to investigate the effects of linear accelerator X-ray irradiation on the structure, mechanics and functional characteristics of red blood cells recovered from patients with malignant tumors during surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erythrocyte Destruction
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2026to 26 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 65 years old who are scheduled to undergo elective surgery for malignant tumors
Who may be able to join
- Patients scheduled for elective surgery for malignant tumors
- Age: 18 - 65 years old
- It is estimated that the surgical bleeding will be greater than or equal to 500 milliliters.
Who cannot join
- Disorders of red blood cell production (such as aplastic anemia, megaloblastic anemia, iron deficiency anemia, leukemia, myelofibrosis, etc.)
- Diseases caused by increased destruction of red blood cells (abnormalities in red blood cell membranes such as hereditary spherocytosis and paroxysmal nocturnal hemoglobinuria; abnormalities in hemoglobin such as thalassemia; abnormalities in red blood cell-related enzymes such as glucose-6-phosphate dehydrogenase deficiency, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, School of Medicine, Zhejiang University,anesthesiology department,
Hangzhou, Zhejiang, 310009
Fengjiang ZHANG, +8613858007629, zrzfj@zju.eud.cn
About this study
Official title: A Multi-dimensional Evaluation of the Effects of Linear Accelerator X-ray Irradiation on the Morphology, Mechanical Properties and Functions of Red Blood Cells
This study aims to investigate the effects of linear accelerator X-ray irradiation on the structure, mechanics and functional characteristics of red blood cells recovered from patients with malignant tumors during surgery. A red blood cell damage evaluation system based on multiple-dimensional indicators is established. Through atomic force microscopy, microfluidic chips and biochemical detection methods, the changes in red blood cell membrane structure, deformability and oxygen-carrying capacity under different irradiation doses are systematically evaluated. The dose-effect relationship between irradiation dose and red blood cell damage degree is clarified, providing experimental evidence for the safe dose of irradiation processing of autologous blood during surgery.
Read the detailed description
This study aims to address the current lack of systematic evaluation methods for the survival status and damage characteristics of red blood cells after irradiation treatment. It is difficult to accurately assess the long-term functional activity of irradiated red blood cells in the body. By combining techniques such as microtubule suction, microfluidic technology, microscopy, and cross-scale numerical simulation, this study will comprehensively evaluate the dynamic changes in the geometric shape, mechanics, and flow characteristics of red blood cells under X-ray irradiation from a linear accelerator from multiple dimensions. It will also explore the cross-scale mechanical mechanisms of the ultrastructure, deformation, and flow characteristics changes of the red blood cell membrane caused by irradiation, providing further preclinical evidence for the transformation application of linear accelerators in the recovery of autologous blood for tumor surgery.
- Conditions
- Erythrocyte Destruction
- Keywords
- Red Blood Cell, linear accelerator, Intraoperative Blood Salvage, Oncologic Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell biochemical indicators
The biochemical changes of the treated red blood cells were detected through methods such as blood gas analyzer and related quantitative ELISA kits.
Measured: 1day
Mechanical characteristics of red blood cells
The mechanical property changes of red blood cells after treatment were detected by techniques such as microtubule suction and microfluidics
Measured: 3 day
Morphological characteristics of red blood cells
Using scanning electron microscope (SEM) and transmission electron microscope (TEM), observe the changes in the surface structure and ultrastructure of the red blood cell membrane. Also, study the morphological alterations of red blood cells.
Measured: 1day
Secondary outcomes (1)
Circulating tumor cell clearance indicator
Adopt the method of immunofluorescence staining for testing, qualitative or half quantitative analysis by fluorescence microscope, in the evaluation of circulating tumor cells in the blood after processing residues.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start28 Jan 2026 (estimated)
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythrocyte DestructionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416045
- Sponsor's protocol ID
- 2024-0164
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-dimensional Evaluation of the Effects of Linear Accelerator X-ray Irradiation on the Morphology, Mechanical Properties and Functions of Red Blood Cells
- ClinicalTrials.gov ID
- NCT07416045
- Acronym / sponsor ID
- 2024-0164
- Conditions
- Erythrocyte Destruction
- Keywords
- Red Blood Cell, linear accelerator, Intraoperative Blood Salvage, Oncologic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of linear accelerator X-ray irradiation on the structure, mechanics and functional characteristics of red blood cells recovered from patients with malignant tumors during surgery. A red blood cell damage evaluation system based on multiple-dimensional indicators is established. Through atomic force microscopy, microfluidic chips and biochemical detection methods, the changes in red blood cell membrane structure, deformability and oxygen-carrying capacity under different irradiation doses are systematically evaluated. The dose-effect relationship between irradiation dose and red blood cell damage degree is clarified, providing experimental evidence for the safe dose of irradiation processing of autologous blood during surgery.
Detailed description
This study aims to address the current lack of systematic evaluation methods for the survival status and damage characteristics of red blood cells after irradiation treatment. It is difficult to accurately assess the long-term functional activity of irradiated red blood cells in the body. By combining techniques such as microtubule suction, microfluidic technology, microscopy, and cross-scale numerical simulation, this study will comprehensively evaluate the dynamic changes in the geometric shape, mechanics, and flow characteristics of red blood cells under X-ray irradiation from a linear accelerator from multiple dimensions. It will also explore the cross-scale mechanical mechanisms of the ultrastructure, deformation, and flow characteristics changes of the red blood cell membrane caused by irradiation, providing further preclinical evidence for the transformation application of linear accelerators in the recovery of autologous blood for tumor surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 65 years old who are scheduled to undergo elective surgery for malignant tumors
Key inclusion criteria (3 listed)
- Patients scheduled for elective surgery for malignant tumors
- Age: 18 - 65 years old
- It is estimated that the surgical bleeding will be greater than or equal to 500 milliliters.
Key exclusion criteria (2 listed)
- Disorders of red blood cell production (such as aplastic anemia, megaloblastic anemia, iron deficiency anemia, leukemia, myelofibrosis, etc.)
- Diseases caused by increased destruction of red blood cells (abnormalities in red blood cell membranes such as hereditary spherocytosis and paroxysmal nocturnal hemoglobinuria; abnormalities in hemoglobin such as thalassemia; abnormalities in red blood cell-related enzymes such as glucose-6-phosphate dehydrogenase deficiency, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Red blood cell biochemical indicators
Time frame: 1day
The biochemical changes of the treated red blood cells were detected through methods such as blood gas analyzer and related quantitative ELISA kits.
Mechanical characteristics of red blood cells
Time frame: 3 day
The mechanical property changes of red blood cells after treatment were detected by techniques such as microtubule suction and microfluidics
Morphological characteristics of red blood cells
Time frame: 1day
Using scanning electron microscope (SEM) and transmission electron microscope (TEM), observe the changes in the surface structure and ultrastructure of the red blood cell membrane. Also, study the morphological alterations of red blood cells.
1 secondary outcome
Circulating tumor cell clearance indicator
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erythrocyte Destruction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengjiang Zhang (+8613858007629, zrzfj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell biochemical indicators (time frame: 1day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.