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Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy

Sponsor
The First Affiliated Hospital of Dalian Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04215861
Collaborator
(none)
1,000
Enrollment
1
Location
24
Anticipated Duration (Months)
41.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy
    Actual Study Start Date :
    Oct 1, 2019
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Oct 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Raman spectra [the 1st day before operation]

      Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected to analyze the signal changes of Raman spectrum

    2. Raman spectra [the 1st day after operation]

      Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected to analyze the signal changes of Raman spectrum

    Secondary Outcome Measures

    1. progression-free survival [through study completion, an average of 1 year]

    2. overall survival [through study completion, an average of 1 year]

    3. objective response rate [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18-80 years old;

    • The patient whose tumor (tissue or cell) was first diagnosed by pathology;

    • Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy;

    • Have relevant indications for treatment and have no contraindications;

    Exclusion Criteria:

    • Severe or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases, etc.);

    • Other circumstances considered inappropriate by the researcher to participate in the study;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China 116000

    Sponsors and Collaborators

    • The First Affiliated Hospital of Dalian Medical University

    Investigators

    • Principal Investigator: Xiaonan Cui, MD,PhD, The First Affiliated Hospital of Dalian Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital of Dalian Medical University
    ClinicalTrials.gov Identifier:
    NCT04215861
    Other Study ID Numbers:
    • PJ-KS-KY-2019-135
    First Posted:
    Jan 2, 2020
    Last Update Posted:
    Jan 2, 2020
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Jan 2, 2020