Predictive Value of CEA and ctDNA in Lung Cancer Recurrence | NCT07170046

Studies
Predictive Value of CEA and ctDNA in Lung Cancer Recurrence

NCT07170046

Sponsor

Guangdong Provincial People's Hospital

Status

Not yet recruiting

Last Update Posted

Sep 12, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lung Carcinoma

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

Apr 2025

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

Sep 15, 2025Estimated

Primary Completion Date

Aug 1, 2027Estimated

Completion Date

Aug 1, 2027Estimated

First Submitted Date

Sep 7, 2025

First Submission Date that Met QC Criteria

Sep 7, 2025

First Posted Date

Sep 12, 2025Actual

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

Sep 7, 2025

Last Update Posted Date

Sep 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study will collect two groups of cohorts: prospective and retrospective.

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

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients from Guangdong Provincial People's Hospital

Sampling Method

Non-Probability Sample

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
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided