Malignant NeoplasmNCT06202534
An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.
An observational study of Malignant Neoplasm, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
To explore the impact of radiotherapy on peripheral blood myeloid-derived suppressor cells (MDSCs), T cells and extramedullary erythroid precursor cells in patients with malignant tumors, and to evaluate the correlation between changes in the proportion of these cells before and after radiotherapy and the efficacy of… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2023to Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Over 18 years old, diagnosed with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, head and neck cancer and requiring radiotherapy, and the above malignant tumors have not metastasized. 2. Complete inspection information. 3. No other serious complications. 4. No infectious diseases. 5. Able and willing to take blood tests. 6. All researchers gave informed consent and signed an informed consent form, which complied with the requirements of the Medical Ethics Committee.
Who may be able to join
- Over 18 years old, diagnosed with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, head and neck cancer and requiring radiotherapy, and the above malignant tumors have not metastasized.
- Complete inspection information.
- No other serious complications.
- No infectious diseases.
- Able and willing to take blood tests.
- All researchers gave informed consent and signed an informed consent form, which complied with the requirements of the Medical Ethics Committee.
Who cannot join
- People with mental illness.
- People with autoimmune system diseases.
- Those combined with serious diseases of other organs.
- Those with severe alcoholism and drug abuse.
- Research subjects who voluntarily withdraw from the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
GuangzhouFPH
Guangzhou, Guangdong, 510000
yong wu, PhD, 86-13640836938, eywuyong@scut.edu.cn
About this study
To explore the impact of radiotherapy on peripheral blood myeloid-derived suppressor cells (MDSCs), T cells and extramedullary erythroid precursor cells in patients with malignant tumors, and to evaluate the correlation between changes in the proportion of these cells before and after radiotherapy and the efficacy of radiotherapy in patients.
Read the detailed description
To clarify the impact of radiotherapy (and/or other treatment combinations) on the proportion of myeloid-derived suppressor cells (MDSCs), T cells and extramedullary erythroid precursor cells in the peripheral blood of patients with malignant tumors, and to evaluate the changes in the proportion of these cells before and after radiotherapy and the relationship between the patients Correlation with the efficacy of radiotherapy. On this basis, it provides theoretical guidance for the determination of new clinical treatment plans.
- Conditions
- Malignant Neoplasm
- Keywords
- Erythroid Precursor Cells
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Before radiotherapy, | Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients before radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells. | |
| During radiotherapy | Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients during radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells. | |
| After radiotherapy | Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients after radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells. | |
| 3 months after radiotherapy | Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients 3 months after radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythroid precursor cells increase after radiotherapy.
Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.
Measured: Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.
Secondary outcomes (1)
Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.
Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.Peripheral blood myeloid-derived suppressor cells (MDSCs) gradually decreased to the pre-radiation level after 3 months of radiotherapy.
Measured: Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.Peripheral blood myeloid-derived suppressor cells (MDSCs) gradually decreased to the pre-radiation level after 3 months of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start8 Aug 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Wu, Guangzhou First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202534
- Sponsor's protocol ID
- K-2023-093-01
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.
- ClinicalTrials.gov ID
- NCT06202534
- Acronym / sponsor ID
- K-2023-093-01
- Conditions
- Malignant Neoplasm
- Keywords
- Erythroid Precursor Cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
To explore the impact of radiotherapy on peripheral blood myeloid-derived suppressor cells (MDSCs), T cells and extramedullary erythroid precursor cells in patients with malignant tumors, and to evaluate the correlation between changes in the proportion of these cells before and after radiotherapy and the efficacy of radiotherapy in patients.
Detailed description
To clarify the impact of radiotherapy (and/or other treatment combinations) on the proportion of myeloid-derived suppressor cells (MDSCs), T cells and extramedullary erythroid precursor cells in the peripheral blood of patients with malignant tumors, and to evaluate the changes in the proportion of these cells before and after radiotherapy and the relationship between the patients Correlation with the efficacy of radiotherapy. On this basis, it provides theoretical guidance for the determination of new clinical treatment plans.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Before radiotherapy, | – | –Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients before radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells. |
| During radiotherapy | – | –Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients during radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells. |
| After radiotherapy | – | –Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients after radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells. |
| 3 months after radiotherapy | – | –Samples were collected from patients with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, and head and neck cancer. 5 ml of peripheral blood was extracted from these patients 3 months after radiotherapy, and flow cytometry was used to detect MDSCs, T cells, and erythroid precursor cells. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Over 18 years old, diagnosed with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, head and neck cancer and requiring radiotherapy, and the above malignant tumors have not metastasized. 2. Complete inspection information. 3. No other serious complications. 4. No infectious diseases. 5. Able and willing to take blood tests. 6. All researchers gave informed consent and signed an informed consent form, which complied with the requirements of the Medical Ethics Committee.
Key inclusion criteria (6 listed)
- Over 18 years old, diagnosed with breast cancer, nasopharyngeal cancer, colorectal cancer, cervical cancer, lung cancer, head and neck cancer and requiring radiotherapy, and the above malignant tumors have not metastasized.
- Complete inspection information.
- No other serious complications.
- No infectious diseases.
- Able and willing to take blood tests.
Key exclusion criteria (5 listed)
- People with mental illness.
- People with autoimmune system diseases.
- Those combined with serious diseases of other organs.
- Those with severe alcoholism and drug abuse.
- Research subjects who voluntarily withdraw from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapy | Other | 3 months after radiotherapy, After radiotherapy, Before radiotherapy,, During radiotherapy |
Primary outcome
Erythroid precursor cells increase after radiotherapy.
Time frame: Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.
Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.
1 secondary outcome
Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.
Time frame: Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.Peripheral blood myeloid-derived suppressor cells (MDSCs) gradually decreased to the pre-radiation level after 3 months of radiotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Malignant Neoplasm, run by Guangzhou First People's Hospital 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yong wu, PhD (86-13640836938, eywuyong@scut.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythroid precursor cells increase after radiotherapy. (time frame: Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.). 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 11 Jan 2024.