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Clinical Trials/NCT05745506
NCT05745506Not yet recruitingNot Applicable

Effect of Sleep Disorder on the Development of Lung Tumors, a Perspective, Single-centered Study

RenJi Hospital0 sites200 target enrollmentStarted: February 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
200
Primary Endpoint
tumor microenvironment in sleep-disordered lung cancer patients
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

tumor microenvironment in sleep-disordered lung cancer patients

Time Frame: 3 months after surgery

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

Secondary Outcomes

  • peripheral blood levels of neurotransmitters in sleep-disordered lung cancer patients(3 months after surgery)
  • Functional brain imaging in sleep-disordered lung cancer patients(3 months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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Effect of Sleep Disorder on the... | Clinical Trial