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

29 maj 2021 uppdaterad av: Chengcheng Guo

Surveillance of Peripheral Blood Lymphocyte Subsets , Immune Function and Associations With Prognosis and Readiness of Return-to-work of CNS Germ Cell Tumor Survivors

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

150

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Chengcheng Guo, MD,PhD
Telefonnummer: 020-87343891
E-post: guochch@sysucc.org.cn

Studera Kontakt Backup

Namn: Hairong Wang
Telefonnummer: +8618862155823
E-post: wanghr@sysucc.org.cn

Studieorter

Kina
- Guangdong
  - Guangzhou, Guangdong, Kina
    - Rekrytering
    - Sun Yat-sen University Cancer Center
    - Kontakt:
      
      Chengcheng Guo
      
      E-post: guochch@sysucc.org.cn

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn
Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Association between level of immune function and overall survival in patients with intracranial germ cell tumors. Tidsram: 6 months	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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chengcheng Guo

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2019

Primärt slutförande (Förväntat)

31 december 2022

Avslutad studie (Förväntat)

31 december 2023

Studieregistreringsdatum

Först inskickad

26 maj 2021

Först inskickad som uppfyllde QC-kriterierna