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Effect of Sleep Disorder on the Development of Lung Tumors

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05745506
Collaborator
(none)
200
Enrollment
46
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational study is to observe the lung tumor development in lung tumor patients with long-term sleep disorder. The main questions it aims to answer are:

  • will long-term sleep disorder promote the malignancy of lung tumor

  • if so, how exactly will the microenvironment of lung tumor change Participants will receive PSQI scale and MRI functional brain imaging before surgery, blood and tumor tissue will be collected during the surgery.

Researchers will set non-sleep disorder group as control group to see if lung tumor microenvironment change when long-term sleep disorder exists in lung tumor patiens.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Sleep Disorder on the Development of Lung Tumors, a Perspective, Single-centered Study
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    CRD

    patients whose PSQI score>5
    non-CRD

    patients whose PSQI score ≦ 5

    Outcome Measures

    Primary Outcome Measures

    1. tumor microenvironment in sleep-disordered lung cancer patients [3 months after surgery]

      we use single cell sequencing to analyze microenvironment alterations of tumor tissues in enrolled patients.

    Secondary Outcome Measures

    1. peripheral blood levels of neurotransmitters in sleep-disordered lung cancer patients [3 months after surgery]

      peripheral blood levels of epinephrine, noradrenaline, 5-HT in sleep-disordered lung cancer patients

    2. Functional brain imaging in sleep-disordered lung cancer patients [3 months after surgery]

      Functional brain imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 18-75 years old

    • elective sublobectomy for primary lung tumor

    • ASA grade I-II

    • Informed consent of the patient or family

    Exclusion Criteria:

    • Combination of serious heart, liver, kidney, central nervous system, blood system, immune system diseases or serious mental illness

    • Combination of other cancers

    • untreated active lung infection

    • patients with preoperative neoadjuvant radiotherapy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Study Director: Weifeng Yu, Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05745506
    Other Study ID Numbers:
    • IIT-2022-0160
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Lung Neoplasms
    Sleep Wake Disorders
    Parasomnias

    Study Results

    No Results Posted as of Feb 27, 2023