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

NCT06202534 | Unknown

• 1 other identifier: K-2023-093-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Keywords

Erythroid Precursor Cells

Outcome Measures

Primary Outcomes (1)

• 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 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.

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

GuangzhouFPH

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

yong wu, PhD

CONTACT

86-13640836938; eywuyong@scut.edu.cn

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: An Observational Clinical Study Plan on the Effects of Radiotherapy on the Immune System of Patients With Malignant Tumors.

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: August 8, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)