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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202534
• Other study ID #: K-2023-093-01
• Status: Recruiting
• Start date: August 8, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Guangzhou First People's Hospital
• Contact: yong wu, PhD
• Phone: 86-13640836938
• Email: eywuyong[@]scut.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 radiotherapy in patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Locations

Country	Name	City	State
China	GuangzhouFPH	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.