Assessment of Early-detection Based on Liquid Biopsy in L... | NCT05275036

Studies
Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies

NCT05275036

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Apr 14, 2022Actual

Enrollment

493Estimated

Phase

Not provided

Conditions

Lymphoma

Interventions

early detection test

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

Apr 2022

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

May 31, 2022Estimated

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Feb 28, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 11, 2022Actual

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

Apr 6, 2022

Last Update Posted Date

Apr 14, 2022Actual

Name	Class
Guangzhou Burning Rock Dx Co., Ltd.	INDUSTRY

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

493Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer Arm		Participants with new diagnosis of lymphoid malignancies, from whom blood samples will be collected.	Device: early detection test
Benign Arm		Participants with new diagnosis of benign lymphoid diseases, from whom blood samples will be collected.	Device: early detection test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
early detection test	Device	Blood collection and early detection testing	Benign Arm Cancer Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The sensitivity and specificity of early detection model for lymphoma based on cfDNA methylation or combined with other biomarkers.		12 months

Secondary Outcomes

Measure	Description	Time Frame
The sensitivity and specificity of the optimal model in lymphoma patients at different clinical stages.		12 months
The sensitivity and specificity of the optimal model in different subtypes of lymphoma patients.		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria for All Participants:

Age 40-75 years at the day of consenting to the study.
Able to provide a written informed consent.

Additional Inclusion Criteria for Cancer Participants:

No prior cancer treatment (local or systematic) prior to blood draw.
High suspicious or pathologically confirmed lymphoid malignancies within 42 days prior to blood draw.

Additional Inclusion Criteria for Benign Disease Participants:

No prior radical treatment of the benign diseases prior to study blood draw
Pathologically confirmed diagnosis of lymphoid benign diseases within 90 days prior to blood draw.

Exclusion Criteria for All Participants:

Insufficient qualified blood samples.
During pregnancy or lactation.
Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
Recipient of blood transfusion within 7 days prior to blood draw.
Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen).

Additional Exclusion Criteria for Cancer Participants:

With other known malignant tumors or multiple primary tumors.
Lymphoid malignancies unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw.

Additional Exclusion Criteria for Benign Disease Participants:

With other known malignant tumors or comfirmed lymphoid malignancies.
Lymphoid benign diseases unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Eligible participants will be recruited from the participating medical center and assigned into two arms, including participants with new diagnosis of lymphoid malignancies and benign lymphoid diseases.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Huiqiang Huang, Ph.D	Contact	+86-020-87343350		huanghq@sysucc.org.cn
Yan Gao, Ph.D	Contact	+86-020-87343350		gaoyan@sysucc.org.cn

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases