Surveillance of Association of Immune Status and Prognosis of CNS Germ Cell Tumor Survivors

NCT04909307 | Unknown

• 1 other identifier: ChengchengGuo
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Platinum-based chemotherapy, alternating at 21-days intervals with cycles of ifosfamide, cisplatin, and etoposide (ICE) and subsequently received radiotherapy were considered as standard treatment for intracranial germ cell tumors. However, whether reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. This project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with CNS germ cell tumors before and after chemoradiotherapy treatment. Meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of therapy.This study is designed to prospectively analyze the dynamic changes of immune status, prognosis and society function after standard treatment in patients with intracranial germ cell tumor.

Conditions

Intracranial Germ Cell Tumor; Intracranial Germ Cell CNS Tumor, Childhood; Surgery

Outcome Measures

Primary Outcomes (1)

• Association between level of immune function and overall survival in patients with intracranial germ cell tumors.

  Patients with intracranial germ cell tumors will be followed, prospectively from the time of discharge using review of the electronic medical record and as local guidance permits, phone calls at 3 and 6 months. The investigators will determine the associations between level of immune function after anti-tumor treatment and the objective remission rate and survival outcomes.

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intracranial germ cell tumors and received anti-tumor therapy, including chemotherapy and radiotherapy.

You may qualify if:

• Primary diagnosis of an intracranial germ cell tumor (Histologically confirmed intracranial non-germinomatous or germinoma germ cell tumor).
• Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm.
• No history of anti-tumor treatment
• Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
• Be willing and able to provide written informed consent/assent for the trial

You may not qualify if:

• Patients with immune function deficiency : immunosuppression status, including autoimmune disease, post-operation of organ transplantation, in-taking immunosuppressive drug, human immunodeficiency virus (HIV) positive patients,
• Known history of active tuberculosis not adequately treated or positive QuantiFERON TB Gold test.
• Hypoproteinemia (eg, in case of severe liver disease or nephrotic syndrome) with serum albumin \<3.0 g/dL.

Sponsors & Collaborators

• Chengcheng Guo: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Chengcheng Guo, MD,PhD

CONTACT

020-87343891; guochch@sysucc.org.cn

Hairong Wang

CONTACT

+8618862155823; wanghr@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, MD, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: June 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)