- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157569
CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia
February 24, 2020 updated by: Liren Qian, Navy General Hospital, Beijing
Monitoring Circulating Tumor DNA After Chemotherapy in Elderly Patients With Acute Leukemia
This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL
Study Overview
Status
Recruiting
Conditions
Detailed Description
This study will use droplet digital PCR (ddPCR) method to quantify peripheral blood plasma mutant allele frequency (MAF) in elderly acute leukemia patients after chemotherapy to evaluate the clinical value of CtDNA .
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liren Qian, MD
- Phone Number: +861066957676
- Email: qlr2007@126.com
Study Locations
-
-
-
Beijing, China, 100048
- Recruiting
- Navy General Hospital
-
Contact:
- Liren Qian, M.D.
- Phone Number: +861066957676
- Email: qlr2007@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population include old AML patients with somatic mutations
Description
Inclusion Criteria:
- Written informed consent
- Male
- not pregnant female
- patients >=60 years old
- Diagnosis of acute leukemia
Exclusion Criteria:
- Pregnancy
- HIV positive
- patients >=100 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cumulative incidence of relapse(CIR)
Time Frame: through study completion, an average of 1 year
|
cumulative incidence of relapse
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival (OS)
Time Frame: through study completion, an average of 2 years
|
overall survival
|
through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Liren Qian, MD, Navy General Hospital, Beijing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2019
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2029
Study Registration Dates
First Submitted
November 4, 2019
First Submitted That Met QC Criteria
November 6, 2019
First Posted (Actual)
November 8, 2019
Study Record Updates
Last Update Posted (Actual)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 24, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NavyGHB-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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