Monitoring Efficacy of Radiotherapy in Lung Cancer and Es... | NCT04014465

Studies
Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer

NCT04014465

Sponsor

Chinese Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Feb 2, 2021Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Lung Cancer
Esophageal Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jul 9, 2019

First Submission Date that Met QC Criteria

Jul 9, 2019

First Posted Date

Jul 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2021

Last Update Posted Date

Feb 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival	the rate of progression free survival for 3 years	3 years

Secondary Outcomes

Measure	Description	Time Frame
overall survival	the rate of overall survival for 3 years	3 years
Adverse Events	Number of Participants with Adverse Events	3 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with lung cancer or esophageal cancer intend to receive radiotherapy in Cancer hospital,Chinese academy of medical sciences.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nan Bi, Doctor	Contact	8613520445135		binan_email@163.com
Tao Zhang, Professor	Contact	8618911006677		zhangt10@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical sciences	Recruiting	Beijing	Beijing Municipality	100021	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28373748	Result	Chen W, Zheng R, Zhang S, Zeng H, Zuo T, Xia C, Yang Z, He J. Cancer incidence and mortality in China in 2013: an analysis based on urbanization level. Chin J Cancer Res. 2017 Feb;29(1):1-10. doi: 10.21147/j.issn.1000-9604.2017.01.01.
25651787	Result	Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

ID	Term
D008175	Lung Neoplasms
D004938	Esophageal Neoplasms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms