NCT05778253

Brief Summary

The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
41mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Mar 2023Sep 2029

First Submitted

Initial submission to the registry

February 23, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2029

Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

5.5 years

First QC Date

February 23, 2023

Last Update Submit

March 18, 2023

Conditions

Lung Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

  • Pathologic completet response (pCR) rate

    pCR rate is defined as the percentage of participants having an absence of residual tumor cells in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

    Up to 1 year

  • ctDNA resolution

    ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathologic complete response (pCR)

    Up to 2 years

  • Development of computer algorithm to identify pCR features

    Development of computer algorithm to identify pCR features

    From retrospective data collection to algorithm development (6 month)

  • Validation of computer algorithm to identify pCR features

    Validation of computer algorithm to identify pCR features

    From prospective data collection to algorithm validation (6 months)

Secondary Outcomes (8)

  • Major pathological response (MPR) rate

    Up to 1 year

  • Objective response rate(ORR)

    Up to 1 year

  • Adverse events (AEs)

    Up to 5 years

  • Perioperative complications rate

    Up to 3 years

  • Health-related Quality of Life

    Up to 5 years

  • +3 more secondary outcomes

Study Arms (1)

Patients with lung Squamous Cell Carcinoma receiving neoadjuvant chemoimmunotherapy

Diagnostic Test: WES and ctDNA detection

Interventions

WES and ctDNA detectionDIAGNOSTIC_TEST

WES and ctDNA detection

Patients with lung Squamous Cell Carcinoma receiving neoadjuvant chemoimmunotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Resectable or potentially resectable stage II-IIIb lung squamous cell carcinoma patients receiving neoadjuvant chemoimmunotherapy

You may qualify if:

  • Histopathology or cytology confirmed the lung squamous cell carcinoma
  • Age ranging from 18 to 75
  • Agree to participate in this study and sign an informed consent form
  • Treatment-naive tumor
  • According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor
  • Sufficient tissue/blood samples are available to meet research requirements
  • The ECOG PS score is 0-1

You may not qualify if:

  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
  • Non-squamous NSCLC
  • Unresectable IIIa-IIIb tumor
  • Patients with solid organ or blood system transplantation
  • Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors
  • Patients with interstitial lung disease
  • Patients with acute or chronic infectious disease
  • Pregnant and lactating women
  • Patients who have undergone other clinical drug trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China

Changsha, Hunan, 410011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Pretreatment biopsy tissue for WES testing Peripheral blood tissue for ctDNA testing

MeSH Terms

Interventions

Exome

Intervention Hierarchy (Ancestors)

GenomeGenetic StructuresGenetic Phenomena

Central Study Contacts

Yan Hu, M.D., Ph.D.

CONTACT

8685296122yanhu@csu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 21, 2023

Study Start

March 23, 2023

Primary Completion (Estimated)

September 23, 2028

Study Completion (Estimated)

September 23, 2029

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations

CN(1)