Effect of Sleep Disorder on the Development of Lung Tumors | NCT05745506

Studies
Effect of Sleep Disorder on the Development of Lung Tumors

NCT05745506

Sponsor

RenJi Hospital

Status

Not yet recruiting

Last Update Posted

Feb 27, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Sleep Disorder, Lung Tumor

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2023Estimated

Primary Completion Date

Jun 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Feb 16, 2023

First Submission Date that Met QC Criteria

Feb 24, 2023

First Posted Date

Feb 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2023

Last Update Posted Date

Feb 27, 2023Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRD		patients whose PSQI score>5
non-CRD		patients whose PSQI score ≦ 5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Other	Not applicable, there is no intervention description in this study.	CRD non-CRD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
tumor microenvironment in sleep-disordered lung cancer patients	we use single cell sequencing to analyze microenvironment alterations of tumor tissues in enrolled patients.	3 months after surgery

Secondary Outcomes

Measure	Description	Time Frame
peripheral blood levels of neurotransmitters in sleep-disordered lung cancer patients	peripheral blood levels of epinephrine, noradrenaline, 5-HT in sleep-disordered lung cancer patients	3 months after surgery
Functional brain imaging in sleep-disordered lung cancer patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Participants are 18-75 years old man or women diagnosed with primary lung tumor.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weifeng Yu	Contact	13901961704		ywf808@yeah.net
Yumiao Shi	Contact	19821850236		shiyumiaoxka@163.com

Overall Officials

Name	Affiliation	Role
Weifeng Yu	Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012893	Sleep Wake Disorders
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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