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Trial record 36 of 127 for:    exosomes

Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome (RadImm01)

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ClinicalTrials.gov Identifier: NCT02890849
Recruitment Status : Unknown
Verified August 2016 by Jianguo Sun, Xinqiao Hospital of Chongqing.
Recruitment status was:  Not yet recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Jianguo Sun, Xinqiao Hospital of Chongqing

Brief Summary:
The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures design information. Thus exploring the consistency analysis of PD-L1 expression level detected in tissues and pExo,guiding clinical practice of radiotherapy combining with immunotherapy.

Condition or disease Intervention/treatment Phase
NSCLC Other: Liquid biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome
Study Start Date : October 2016
Estimated Primary Completion Date : June 2019

Arm Intervention/treatment
Experimental: a prospective, open, self-controlled phase I clinical study
The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.by using variance analysis of repeated measures design information.
Other: Liquid biopsy



Primary Outcome Measures :
  1. The match rate of PD-L1 protein expression in cancer tissue and PD-L1 mRNA expression in pExo. [ Time Frame: up to one and a half years ]

Secondary Outcome Measures :
  1. The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue. [ Time Frame: up to one and a half years ]

Other Outcome Measures:
  1. Correlation between PD-L1 mRNA expression in pExo and immune indexes. [ Time Frame: up to one and a half years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathological histology and/or cytology confirmed malignant tumor;
  2. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.

Exclusion Criteria:

  1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
  2. Patients with a history of autoimmune disease;
  3. Patients with participating in other clinical trials at the same time;
  4. Other cases that researchers believe that patients should not participate in the present trial.

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Responsible Party: Jianguo Sun, Deputy Director, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT02890849     History of Changes
Other Study ID Numbers: XQonc-004
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016