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Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04014465
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 12, 2019
Information provided by (Responsible Party):
Tao Zhang, Chinese Academy of Medical Sciences

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.

Condition or disease
Lung Cancer Esophageal Cancer

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Efficacy of Radiotherapy Based on Next Generation Sequencing Liquid Biopsy Technique in Lung Cancer and Esophageal Cancer: a Prospective Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

patients with radiotherapy
The patients of lung cancer or esophagueal cancer, who received definitvie RT, should included in this Cohort.

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 3 years ]
    the rate of progression free survival for 3 years

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]
    the rate of overall survival for 3 years

  2. Adverse Events [ Time Frame: 3 years ]
    Number of Participants with Adverse Events

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04014465

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Contact: Nan Bi, Doctor 8613520445135
Contact: Tao Zhang, Professor 8618911006677

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China, Beijing
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Department of Radiation Oncology         
Sponsors and Collaborators
Chinese Academy of Medical Sciences

Publications of Results:
Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Grönroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Quinn AM, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG, Swanton C. Corrigendum: Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2018 Feb 8;554(7691):264. doi: 10.1038/nature25161. Epub 2017 Dec 20.

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Responsible Party: Tao Zhang, Principal Investigator, Chinese Academy of Medical Sciences Identifier: NCT04014465     History of Changes
Other Study ID Numbers: NCC1923
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tao Zhang, Chinese Academy of Medical Sciences:
lung cancer
esophageal cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Esophageal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases