NCT04157569

Brief Summary

This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Nov 2019Dec 2029

First Submitted

Initial submission to the registry

November 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Expected
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

5.2 years

First QC Date

November 4, 2019

Last Update Submit

February 24, 2020

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

  • cumulative incidence of relapse(CIR)

    cumulative incidence of relapse

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • overall survival (OS)

    through study completion, an average of 2 years

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population include old AML patients with somatic mutations

You may qualify if:

  • Written informed consent
  • Male
  • not pregnant female
  • patients \>=60 years old
  • Diagnosis of acute leukemia

You may not qualify if:

  • Pregnancy
  • HIV positive
  • patients \>=100 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navy General Hospital

Beijing, 100048, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

venipuncture peripheral blood bone marrow finger stick peripheral blood saliva

Study Officials

  • Liren Qian, MD

    Navy General Hospital, Beijing

    STUDY CHAIR

Central Study Contacts

Liren Qian, MD

CONTACT

+861066957676qlr2007@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 8, 2019

Study Start

November 5, 2019

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2029

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

CN(1)