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Clinical Trials/NCT04014465
NCT04014465
Unknown
Not Applicable

Monitoring Efficacy of Radiotherapy Based on Next Generation Sequencing Liquid Biopsy Technique in Lung Cancer and Esophageal Cancer: a Prospective Study

Chinese Academy of Medical Sciences1 site in 1 country150 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Chinese Academy of Medical Sciences
Enrollment
150
Locations
1
Primary Endpoint
progression free survival
Last Updated
5 years ago

Overview

Brief Summary

Lung cancer, one of the malignant tumors which poses a threat to human's health, has increased morbidity and mortality recently. Radiotherapy, as one of the common treatments, has important value in clinical application. Esophageal cancer, one of the most common digestive system cancers, has poor prognosis and high mortality. Esophageal cancer has high aggressive and many patients can't get surgical treatment because of the tumor metastasis at the time of diagnosis.Currently, chemoradiotherapy has become one of the standard treatment regimens for patients with unresectable esophageal cancer in National Comprehensive Cancer Network(NCCN). So radiotherapy is one of the most important treatments in esophageal cancer.

Currently, the efficacy evaluation method of radiotherapy is by imaging examination after several courses of treatment. However, new reports suggest that circulating tumor DNA(ctDNA) has the potential to be an indicator of therapeutic effectiveness and recurrence risk.

Detailed Description

Circulating free DNA (cfDNA) can be found dissolved in plasma and serum, at variable amounts. In the case of cancer patients, ctDNA is a fraction of the cfDNA derived from tumor. Currently, the ctDNA is widely used in "liquid biopsy" for not only does it carry the same somatic alterations as the tumor itself but also its percentage is correlated with tumor burden. This study will investigate the clinical value of efficacy evaluation and prognosis of ctDNA detecting technique in patients with radiotherapy.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
December 1, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tao Zhang

Principal Investigator

Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • Patients with histopathological proved lung cancer or esophageal cancer.
  • Candidate for radiotherapy.
  • No history of prior anti-tumor treatment.
  • Eastern Cooperative Oncology Group (ECOG) score 0,
  • Being able to receive computed tomography (CT) and magnetic resonance imaging (MRI).
  • Blood sample is available for dynamic monitoring.
  • Written informed consent provided.
  • Good compliance in the follow-up.

Exclusion Criteria

  • Had received radiotherapy, chemotherapy, biotherapy or other treatment that is related to lung cancer or esophageal cancer.
  • The patients have the sign of any serious or uncontrolled systematic diseases that may have significant impact on the balance between risk and benefit, such as hypertension, infection of hepatitis B, hepatitis C or human immunodeficiency virus(HIV).
  • With history of alcohol or drug abuse.

Outcomes

Primary Outcomes

progression free survival

Time Frame: 3 years

the rate of progression free survival for 3 years

Secondary Outcomes

  • overall survival(3 years)
  • Adverse Events(3 years)

Study Sites (1)

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