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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    150
  • sponsor
    Chengcheng Guo
Updated on 12 June 2021

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.

Description

Immune status influences the reaction of anti-tumor and health condition of intracranial germ cell tumor patients. Peripheral blood and cerebrospinal fluid lymphocytes subsets, cytokines reflects those and be measured. Therefore, we designed the study to estimate patients health condition and survival outcomes in order to provides diversified assessment methods.

Peripheral blood will be collected from patients who will undergo surgery and/or neoadjuvant or adjuvant chemoradiotherapy. The setting time is before chemoradiotherapy, finishing chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. These blood samples will be used for detection and analysis in lymphocyte and immunocyte by flow cytometry.

Details
Condition Intracranial Germ Cell CNS Tumor, Childhood, Surgery, surgeries, surgical procedure, Surgical aspects, surgical procedures, Intracranial Germ Cell Tumor, surgical treatment
Clinical Study IdentifierNCT04909307
SponsorChengcheng Guo
Last Modified on12 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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