MedDataX Logo

Perioperative Symptom Study of Lung Cancer (CN-PRO-Lung 1)

NCT ID: NCT03341377

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

512 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-21

Study Completion Date

2020-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. With at least 300 patients with initial diagnosis of lung cancer and scheduled for surgery, this study will administer symptom assessments (MDASI-LC) and quality of life assessments (SIQOL) before surgery (typically within 3 days before surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4 weeks (±3 days) or the start day of postoperative oncologic treatment. In the upgraded research protocol, symptom and quality of life assessments (every 3 month for 1 year, every 6 month for 2-3 year, every 12 month for 4-5 year), as well as the follow-up of clinical outcomes will continue until 5 years after surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient-reported Outcomes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lung cancer surgical patients

Patient-reported symptom assessments in patients undergoing lung cancer surgery.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Be pathologically or clinically diagnosed as primary lung cancer before surgery;
2. Plan to undergo a surgical procedure.

Exclusion Criteria

1. Aged younger than 18;
2. Diagnosis of cognitive impairment or unable to understand the study requirements.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

Zigong No.1 Peoples Hospital

OTHER

Sponsor Role collaborator

Jiangyou People's Hospital

UNKNOWN

Sponsor Role collaborator

Chengdu Third People's Hospital

UNKNOWN

Sponsor Role collaborator

Chengdu Seventh People's Hospital

UNKNOWN

Sponsor Role collaborator

Dazhu County People's Hospital

UNKNOWN

Sponsor Role collaborator

Xiaojun Yang

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiaojun Yang

Clinical Professor and Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiaojun Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Sichuan Cancer Hospital and Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China

Site Status

Chengdu Seventh People's Hospital

Chengdu, Sichuan, China

Site Status

Chengdu Third People's Hospital

Chengdu, Sichuan, China

Site Status

Dazhu County People's Hospital

Dazhou, Sichuan, China

Site Status

Jiangyou People's Hospital

Jiangyou, Sichuan, China

Site Status

Zigong First People's Hospital

Zigong, Sichuan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Liao J, Hu X, Wei X, Dai W, Yu H, Tian X, Wang Y, Qin Q, Xu N, Li Y, Li Q, Shi Q, Liu X. Sex-related differences in postoperative patient-reported outcomes among lung cancer patients: a multicenter cohort study. BMC Cancer. 2025 Apr 29;25(1):800. doi: 10.1186/s12885-025-14191-z.

Reference Type DERIVED
PMID: 40301835 (View on PubMed)

Wei X, Yu H, King-Kallimanis B, Liu Y, Huang L, Dai W, Yang D, Zhou X, Li Q, Shi Q. Long-Term Function Recovery Following Upper Versus Lower Lobectomy for Lung Cancer: A Multicenter Longitudinal Cohort Study. Thorac Cancer. 2025 Jan;16(1):e15505. doi: 10.1111/1759-7714.15505. Epub 2024 Dec 13.

Reference Type DERIVED
PMID: 39670353 (View on PubMed)

Dai W, Xie S, Zhang R, Wei X, Wu C, Zhang Y, Feng W, Liao X, Mu Y, Zhou H, Cheng X, Jiang Y, He J, Li Q, Yang X, Shi Q. Developing and validating utility parameters to establish patient-reported outcome-based perioperative symptom management in patients with lung cancer: a multicentre, prospective, observational cohort study protocol. BMJ Open. 2019 Oct 28;9(10):e030726. doi: 10.1136/bmjopen-2019-030726.

Reference Type DERIVED
PMID: 31662377 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCCHEC-02-2017-042

Identifier Type: -

Identifier Source: org_study_id