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Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT04014465
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tao Zhang, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date July 9, 2019
First Posted Date July 10, 2019
Last Update Posted Date July 12, 2019
Actual Study Start Date February 1, 2019
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2019)
progression free survival [ Time Frame: 3 years ]
the rate of progression free survival for 3 years
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04014465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 9, 2019)
  • overall survival [ Time Frame: 3 years ]
    the rate of overall survival for 3 years
  • Adverse Events [ Time Frame: 3 years ]
    Number of Participants with Adverse Events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer
Official Title Monitoring Efficacy of Radiotherapy Based on Next Generation Sequencing Liquid Biopsy Technique in Lung Cancer and Esophageal Cancer: a Prospective Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
plasma
Sampling Method Non-Probability Sample
Study Population patients with lung cancer or esophageal cancer intend to receive radiotherapy in Cancer hospital,Chinese academy of medical sciences.
Condition
  • Lung Cancer
  • Esophageal Cancer
Intervention Not Provided
Study Groups/Cohorts patients with radiotherapy
The patients of lung cancer or esophagueal cancer, who received definitvie RT, should included in this Cohort.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 9, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
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 0,1.
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nan Bi, Doctor 8613520445135 binan_email@163.com
Contact: Tao Zhang, Professor 8618911006677 zhangt10@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04014465
Other Study ID Numbers NCC1923
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Tao Zhang, Chinese Academy of Medical Sciences
Study Sponsor Chinese Academy of Medical Sciences
Collaborators Not Provided
Investigators Not Provided
PRS Account Chinese Academy of Medical Sciences
Verification Date July 2019