Lung CarcinomaNCT07170046
Predictive Value of CEA and ctDNA in Lung Cancer Recurrence
An observational study of Lung Carcinoma, run by Guangdong Provincial People's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Lung Carcinoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from Guangdong Provincial People's Hospital
Who may be able to join
- 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
Who cannot join
- Those without available imaging records
- Patients with a history of malignant tumors within the past five years
- Patients with secondary lung cancer
About this study
Official title: Predictive Value of CEA and ctDNA for Postoperative Recurrence in Patients With High CEA Sensitivity Lung Cancer
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.
Read the detailed description
This study will collect two groups of cohorts: prospective and retrospective.
- Conditions
- Lung Carcinoma
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170046
- Sponsor's protocol ID
- KY2025-310
- Status last verified
- Apr 2025
- First submitted
- 7 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of CEA and ctDNA for Postoperative Recurrence in Patients With High CEA Sensitivity Lung Cancer
- ClinicalTrials.gov ID
- NCT07170046
- Acronym / sponsor ID
- KY2025-310
- Conditions
- Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from Guangdong Provincial People's Hospital
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Those without available imaging records
- Patients with a history of malignant tumors within the past five years
- Patients with secondary lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative tumor recurrence or progression
Time frame: 2 years
If the tumor recurs or progresses within 2 years, it will be marked as 1. If not, it will be marked as 0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Carcinoma, run by Guangdong Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative tumor recurrence or progression (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.