NCT05275036

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
493

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

February 28, 2022

Last Update Submit

April 6, 2022

Conditions

Lymphoma

Keywords

lymphoma, early detection, liquid biopsy

Outcome Measures

Primary Outcomes (1)

  • The sensitivity and specificity of early detection model for lymphoma based on cfDNA methylation or combined with other biomarkers.

    12 months

Secondary Outcomes (3)

  • 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

  • The rate of high-risk patients found by prognostic model for lymphoma based on cfDNA methylation or combined with other biomarkers.

    24 months

Study Arms (2)

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

early detection testDEVICE

Blood collection and early detection testing

Benign ArmCancer Arm

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SunYat-sen university cancer center

Guangzhou, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma, white blood cells

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Huiqiang Huang, Ph.D

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqiang Huang, Ph.D

CONTACT

+86-020-87343350huanghq@sysucc.org.cn

Yan Gao, Ph.D

CONTACT

+86-020-87343350gaoyan@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 11, 2022

Study Start

May 31, 2022

Primary Completion

June 30, 2023

Study Completion

August 31, 2025

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

CN(1)