Clinical trial NCT06202534: An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.
Official title: An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Neoplasm
Keywords: Erythroid Precursor Cells
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. People with mental illness.
2. People with autoimmune system diseases.
3. Those combined with serious diseases of other organs.
4. Those with severe alcoholism and drug abuse.
5. Research subjects who voluntarily withdraw from the study.

Primary outcomes:
measure: Erythroid precursor cells increase after radiotherapy.
timeFrame: Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.
Secondary outcomes:
measure: Peripheral blood myeloid-derived suppressor cells (MDSCs) increase after radiotherapy.
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: GuangzhouFPH
state: Guangdong
Study officials:
References: