NSCLCPeri-RNCT06610240
Perioperative Treatment Outcomes of Early NSCLC
An observational study of NSCLC, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes of perioperative NSCLC patients receiving different treatment strategies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Oct 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: stage I-III NSCLC under different perioperative treatment
Who may be able to join
- Stage I-III NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
- Patients who have undergone radical lung cancer surgery.
- Patients who have received neoadjuvant treatment before radical lung cancer surgery, including chemotherapy, targeted therapy, or immunotherapy both alone or combined.
Who cannot join
- Patients with other previous malignancies, except those who achieved complete remission at least two years before radical lung cancer surgery and did not require additional treatment.
- Patients with incomplete key baseline and treatment information，including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
- Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
- Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Perioperative Treatment Patterns and Clinical Outcomes in Early-Stage Non-Small Cell Lung Cancer: a Real-World Observational Study
This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes of perioperative NSCLC patients receiving different treatment strategies. According to the inclusion and exclusion criteria, perioperative NSCLC patients admitted to the study center from January 1, 2020, to one year after the study initiation will be retrospectively screened and collected.
- Conditions
- NSCLC
- Keywords
- NSCLC；, perioperative treatment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival
the time from randomization to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause;
Measured: From date of diagnosis until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 36 months
overall survival
from diagnosis to death
Measured: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (3)
R0 resection rate
margin negative resection
Measured: usually 1 week after surgery
major pathological response
viable tumor cell less than 10%
Measured: usually 1 week after surgery
p-CR
no viable tumor cells was observed
Measured: usually 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Nov 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhong, Shanghai Chest Hospital
- Investigators
- Zhong Dr., MD, Study chair, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610240
- Sponsor's protocol ID
- IS24118
- Acronym
- Peri-R
- Status last verified
- Nov 2024
- First submitted
- 11 Sep 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we need to further analyze the data
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Treatment Patterns and Clinical Outcomes in Early-Stage Non-Small Cell Lung Cancer: a Real-World Observational Study
- ClinicalTrials.gov ID
- NCT06610240
- Acronym / sponsor ID
- Peri-R / IS24118
- Conditions
- NSCLC
- Keywords
- NSCLC；, perioperative treatment
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 24 Sep 2024 (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.
This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes of perioperative NSCLC patients receiving different treatment strategies. According to the inclusion and exclusion criteria, perioperative NSCLC patients admitted to the study center from January 1, 2020, to one year after the study initiation will be retrospectively screened and collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- stage I-III NSCLC under different perioperative treatment
Key inclusion criteria (3 listed)
- Stage I-III NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
- Patients who have undergone radical lung cancer surgery.
- Patients who have received neoadjuvant treatment before radical lung cancer surgery, including chemotherapy, targeted therapy, or immunotherapy both alone or combined.
Key exclusion criteria (4 listed)
- Patients with other previous malignancies, except those who achieved complete remission at least two years before radical lung cancer surgery and did not require additional treatment.
- Patients with incomplete key baseline and treatment information，including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
- Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
- Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
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
event-free survival
Time frame: From date of diagnosis until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 36 months
the time from randomization to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause;
overall survival
Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
from diagnosis to death
3 secondary outcomes
R0 resection rate
Time frame: usually 1 week after surgery
major pathological response
Time frame: usually 1 week after surgery
p-CR
Time frame: usually 1 week after surgery
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 13 Nov 2024.
- Individual participant dataSharing planned: Undecided. we need to further analyze the data
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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.
Zhong Dr., MD study chair
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Shanghai Chest Hospital at 1 site in China.
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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
event-free survival (time frame: From date of diagnosis until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 36 months). The study lists 2 primary outcomes in all. 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 13 Nov 2024.