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Chromosomal Instability as a Surrogate Biomarker of Drug Resistance in Immunotherapy for Lung Cancer Patients

NCT04203095 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2019-12-24

No results posted yet for this study

Summary

PD1, as an immune checkpoint inhibitor, has provided a new therapeutic approach for patients with cancer, including patients. Although immunotherapy has proven effective, most patients do not benefit from it because of a large proportion which developing primary and acquired resistance. However, there is still a lack of accurate and effective molecular biomarkers to accurately evaluate the drug resistance of patients treated with immune checkpoint inhibitors (ICI), so as to maximize the therapeutic effect in patients. Chromosomal instability (CIN) is one of the most prominent and common characteristics of solid tumors, accelerating the development of anti-cancer drug resistance, often leading to treatment failure and disease recurrence, which limits the effectiveness of most current treatments. Hence the aim of this study is to evaluate dynamic CIN continuously monitored in the blood of patients with lung cancer treated with ICIs with Ultrasensitive Chromosomal Aneuploidy Detection (UCAD) to establish a new molecular immune resistance evaluation index. Further, the correlation between the evolution of tumor cloning and ICI resistance in patients during treatment was analyzed based on the results of dynamic CIN detection. This not only evaluate the efficacy of the ICI treatment in real-time, but also enables better understanding and overcoming the resistance mechanism of immunotherapy in the future.

Conditions

Interventions

DIAGNOSTIC_TEST

the level of plasma cfDNA CINs

The extracted cfDNA from PB will be analyzed by UCAD to determine the level of CINs.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Principal Investigators

  • Di Zheng, PhD · Shanghai Pulmonary Hospital, Shanghai, China

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-10
Primary Completion
2020-11-11
Completion
2021-11-11

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203095 on ClinicalTrials.gov