NCT07170046

Brief Summary

The study aims to investigate the predictive value of CEA levels for postoperative recurrence in the highly sensitive CEA lung cancer patients and to explore whether the dynamic changes of postoperative CEA and MRD in this population are related.This study was carried out to accurately predict the recurrence time, save the time and cost of changing the intervention strategy, and provide more personalized treatment for patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Sep 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Sep 2025Aug 2027

First Submitted

Initial submission to the registry

September 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 12, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

September 7, 2025

Last Update Submit

September 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative tumor recurrence or progression

    If the tumor recurs or progresses within 2 years, it will be marked as 1. If not, it will be marked as 0.

    2 years

Study Arms (2)

retrospective cohort

The clinical information of the population in this cohort was retrospectively collected.

prospective cohort

The clinical information of the population in this cohort was prospectively collected.

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from Guangdong Provincial People's Hospital

You may qualify if:

  • Preoperative CEA \> 5mg/l
  • MRD testing was conducted before the operation
  • The primary lesion was resected through surgery
  • There should be at least two CEA and MRD follow-up tests within 2 years after the operation
  • Postoperative pathology confirmed it as a malignant lung tumor

You may not qualify if:

  • Those without available imaging records
  • Patients with a history of malignant tumors within the past five years
  • Patients with secondary lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2025

First Posted

September 12, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 12, 2025

Record last verified: 2025-04