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

NCT ID: NCT05275036

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

493 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2025-08-31

Brief Summary

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ASCEND-LYM is a prospective, multi-center, observational study aimed at detecting early stage lymphoma and constrcuting prognostic model by combined assays of cfDNA methylation and other biomarkers. The study will enroll approximately 493 participants including lymphoid malignancies and benign diseases.

Detailed Description

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Conditions

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Lymphoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer Arm

Participants with new diagnosis of lymphoid malignancies, from whom blood samples will be collected.

early detection test

Intervention Type DEVICE

Blood collection and early detection testing

Benign Arm

Participants with new diagnosis of benign lymphoid diseases, from whom blood samples will be collected.

early detection test

Intervention Type DEVICE

Blood collection and early detection testing

Interventions

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early detection test

Blood collection and early detection testing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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


* 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.


* 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

* 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).


* 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.


* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Burning Rock Dx Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Huiqiang Huang

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huiqiang Huang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology, Sun Yat-sen University Cancer Center

Locations

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SunYat-sen university cancer center

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huiqiang Huang, Ph.D

Role: CONTACT

+86-020-87343350

Yan Gao, Ph.D

Role: CONTACT

+86-020-87343350

Facility Contacts

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Yan Gao

Role: primary

Other Identifiers

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BRCD2022003

Identifier Type: -

Identifier Source: org_study_id

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