NCT07779005

Brief Summary

Modifiable risk factors, including smoking, alcohol consumption, and diet, play critical roles in cancer progression and patient prognosis. In patients diagnosed with lung cancer, these risk factors not only directly modulate host metabolism and immune regulation, but also exert indirect effects by altering the internal milieu, such as the gut microbiota-potentially exerting a profound impact on long-term clinical trajectories. Leveraging a well-characterized, longitudinally followed cohort of confirmed lung cancer patients, this study systematically assesses habitual dietary intake, emotional well-being, lifestyle behaviors, and related variables using validated instruments, including the Food Frequency Questionnaire (FFQ). Furthermore, the study integrates multidimensional biomarker profiling across tumor tissue, blood, urine, and fecal samples. By linking exposure profiles, multi-omics data, and long-term clinical follow-up records, this project aims to:

  1. 1.Evaluate Prognostic Associations: Investigate the relationships between exposure profiles (e.g., dietary patterns) and long-term clinical outcomes in lung cancer patients, including progression-free survival (PFS), overall survival (OS), and recurrence risk.
  2. 2.Elucidate Biological Mechanisms: Unravel the underlying mechanisms by which the "exposure profile-multi-omics" axis mediates lung cancer progression, and identify candidate biomarkers with predictive value for clinical prognosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Feb 2019Dec 2029

Study Start

First participant enrolled

February 1, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Expected
Last Updated

August 21, 2026

Status Verified

June 1, 2026

Enrollment Period

5.9 years

First QC Date

August 19, 2026

Last Update Submit

August 19, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 6-Month Progression-Free Survival (PFS) Rate

    6 months

  • Overall Survival (OS)

    From enrollment through study completion, up to 10 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Starting in February 2019, patients with histologically or cytologically confirmed lung cancer who received treatment and follow-up at Shengjing Hospital of China Medical University were enrolled in this study. Clinical and demographic characteristics were extracted from the electronic medical record (EMR) system, lifestyle habits and related exposure data were collected using a validated Food Frequency Questionnaire (FFQ), and high-quality follow-up was conducted on a regular basis.

You may qualify if:

  • Patients aged between 18 and 75 years;
  • Patients with newly, pathologically confirmed lung cancer;
  • Patients diagnosed within the preceding 6 months (time since confirmed diagnosis \< 6 months).

You may not qualify if:

  • Individuals aged outside the range of 18-75 years, or those in poor general physical condition who are unable to cooperate with the questionnaire survey;
  • Patients with non-primary lung cancer, non-newly diagnosed lung cancer, or those unable to provide definitive pathological confirmation;
  • Individuals with severe depression, pregnant women, or those diagnosed with severe cardiovascular/cerebrovascular diseases or severe metabolic dysfunctions affecting the liver, kidneys, or other major organs;
  • Individuals unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

Central Study Contacts

Huanhuan Chen Dr.Chen

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shengjing Hospital of China Medical University

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 21, 2026

Study Start

February 1, 2019

Primary Completion

December 30, 2024

Study Completion (Estimated)

December 31, 2029

Last Updated

August 21, 2026

Record last verified: 2026-06

Locations