CtDNA After Chemotherapy in Elderly Patients With Acute L... | NCT04157569

Studies
CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia

NCT04157569

Sponsor

Navy General Hospital, Beijing

Status

Recruiting

Last Update Posted

Feb 25, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Acute Leukemia

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Nov 4, 2019

First Submission Date that Met QC Criteria

Nov 6, 2019

First Posted Date

Nov 8, 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

Feb 24, 2020

Last Update Posted Date

Feb 25, 2020Actual

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

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

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 .

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cumulative incidence of relapse(CIR)	cumulative incidence of relapse	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
overall survival (OS)	overall survival	through study completion, an average of 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The population include old AML patients with somatic mutations

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Liren Qian, MD	Contact	+861066957676		qlr2007@126.com

Overall Officials

Name	Affiliation	Role
Liren Qian, MD	Navy General Hospital, Beijing	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Navy General Hospital	Recruiting	Beijing		100048	China