An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: yong wu, PhD; Phone Number: 86-13640836938; Email: eywuyong@scut.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • GuangzhouFPH
      • Contact: yong wu, PhD; Phone Number: 86-13640836938; Email: eywuyong@scut.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Erythroid precursor cells increase after radiotherapy.Erythroid precursor cells gradually decreased to the pre-radiation level after 3 months of radiotherapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 1, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Erythroid Precursor Cells
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: K-2023-093-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No