Perioperative Treatment Outcomes of Early NSCLC

NCT06610240 | Enrolling By Invitation

• 1 other identifier: IS24118
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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;

  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

  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

  usually 1 week after surgery

• major pathological response

  usually 1 week after surgery

• p-CR

  usually 1 week after surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

stage I-III NSCLC under different perioperative treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Zhong Hua

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhong Dr., MD

  Shanghai Chest Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 24, 2024
• Study Start: November 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

CN (1)