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

Study Locations

  • China
      • Beijing, China, 100048
        • Recruiting
        • Navy General Hospital
        • Contact:

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

Navy General Hospital, Beijing

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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